ࡱ>  Mbjbj   A,A,A,A,A,U,U,U,8, 8U,8F5>(]>(>>>.@:hA\A0$~ pA,B @".@BBA,A,>> BaA,>A,>B>lU,q<86h,A,A"B.BBBAAAovAAA8BBBBAAAAAAAAA +:QIBA v-CT Chest V1.4 2010.09.09 X. Imaging Protocol <> Instructions to Clinical Trialists who are adapting this imaging protocol for inclusion in their Clinical Trial Protocol are shown in italics. All italic text should generally be removed as part of preparing the final protocol text. 0. Executive Summary This protocol describes image acquisition, processing, analysis, change measurements and interpretation for quantitatively evaluating the progression/regression of measurable target lesions, that is, lung tumors greater than 1cm in Longest Diameter (LD) at baseline that are selected for follow up during a course of treatment. It is intended to provide twice the sensitivity of using sum of longest diameters (SLD) as the basis for RECIST 1.1. The protocol uses the sum of whole tumor volumes instead of SLDs as the basis for RECIST. Otherwise, most all of the definitions and rules described by RECIST 1.1 still apply. The only exceptions are that there need not be a limit on the number of measurable target lesions selected, as the long-term goal is to quantify the whole tumor burden suffered by a given patient at each time-point during treatment. 1. Context of the Imaging Protocol within the Clinical Trial 1.1. Utilities and Endpoints of the Imaging Protocol This image acquisition and processing protocol is appropriate for quantifying the volumes of solid tumors of the lung, and longitudinal changes in volumes within subjects. Following this protocol is expected to provide intra-rater test-retest precision of measurement for whole tumor volume of no less than 18%. This value should be twice as sensitive as RECIST, based on the idea that for uniformly expanding cubes and solid spheres, a 20% increase in the RECIST defined uni-dimensional Longest Diameter of a Measurable Lesion corresponds to an increase in volume of about 73%, and to diagnose Progressive Disease at a change of about one half that volume, 36%, the noise needs to be less than about 18%. This protocol is otherwise agnostic to the clinical settings in which the measurements are made and the way the measurements will be used to make decisions about individual patients with cancer or new treatments for patients with cancer. Typical uses might include assessing response to treatment, establishing the presence of certain progression events for determining TTP, PFS, etc., distinguishing between arms of clinical trials, or determining eligibility of potential subjects in clinical trials. 1.2. Timing of Imaging within the Clinical Trial Calendar This protocol does not presume a specific timing. Generally, per RECIST 1.1, "all baseline evaluations should be performed as close as possible to the treatment start". In clinical trials, there is an expectation that follow up scans will be acquired at regular, protocol-specific intervals. 1.3. Management of Pre-enrollment Imaging To quantify volumes and volume changes with the precision claimed in this protocol, the pre-treatment image acquisition and processing must meet or exceed the minimum specifications described in this protocol. Scans that meet criteria can serve as the baseline scan on which change measurements are based. Management of pre-enrollment imaging, including decisions about whether to accept lower precision or to require a new, protocol-specific baseline scan, are left to each specific clinical trial protocol author. 1.4. Management of On-Protocol Imaging Performed Off-Schedule This protocol does not presume a universal, or even a specific imaging schedule. It is intended to measure tumor volume change between two arbitrary time points, including scans that are acquired outside of the protocol-specified time-window (OOW scans). Management of the clinical trial calendar, deviations from the protocol specified time window, and potential impacts of deviations or non-uniformity of interval timing on derived outcomes such are Time-To-Progression (TTP) or Progression-Free-Survival (PFS) are left to each clinical trial protocol author. 1.5. Management of On-Protocol Imaging Performed Off-Specification Deviation from the image resolution specifications defined in this protocol will likely degrade the quality of measurements. Management of off-specification imaging, including decisions about whether to accept lower precision scans or to require repeat scans, are left to the clinical trial protocol author. 1.6. Management of Unscheduled, Off-Protocol Imaging Unscheduled imaging examinations that are not part of the protocol specified procedures for measuring tumor volumes may be used as indicators of progression only. For example, in a subject with lung cancer who is being followed with CT scans of the body, if an unscheduled, off-protocol MRI scan of the head is acquired in the middle of a cycle to evaluate a new complaint of headache, then it may be read either as confirming progression or being negative for progression depending on whether or not new brain metastases are discovered. 1.7. Subject Selection Criteria Related to Imaging 1.7.1. Relative Contraindications and Mitigations This protocol involves ionizing radiation. Risk and Safety considerations, e.g., for young children or pregnant women, are referenced in section 13.1. Local standards for good clinical practice (cGCP) and the ALARA Principle (As Low As Reasonably Achievable radiation exposure) should be followed. This protocol involves the use of intravenous contrast. Risk and Safety considerations, e.g., for subjects with chronic renal failure, are referenced in section 13.2. Local standards for good clinical practice (cGCP) should be followed. The use of contrast in section 5 assumes there are no known contra-indications in a particular subject. 1.7.2. Absolute Contraindications and Alternatives There are few, if any, absolute contra-indications to the CT image acquisition and processing procedures described in this protocol. Local standards for good clinical practice (cGCP) should be followed. Magnetic resonance imaging (MRI) may be used when clinical indicated (e.g., to evaluate metastases to the liver). However, the measurement of tumor volume with non-CT based imaging technologies is outside the scope of this protocol. 2. Site Selection, Qualification and Training 2.1. Personnel Qualifications This protocol does not presume specific personnel or qualifications beyond those normally required for the performance and interpretation of CT exams with contrast. Local rules and regulations for the certification of personnel providing patient care should be followed. Responsibilities for the qualification and maintenance of certification of image analysts in clinical trials is left to each clinical trial sponsor. 2.2. Imaging Equipment This protocol requires a CT scanner with the following characteristics: while multi-slice is not required, it will produce better results. Acceptable: Single slice, Target: 16 detectors or greater, Ideal: 64 or greater see section 7 for required acquisition capabilities conforms to the Medical Device Directive Quality System and the Essential Requirements of the Medical Device Directive designed and tested for safety in accordance with IEC 601-1, as well as for ElectroMagnetic Compatibility (EMC) in accordance with the European Unions EMC Directive, 89/336/EEC Labelled for these requirements, as well as ISO 9001 and Class II Laser Product, at appropriate locations on the product and in its literature CSA compliant Measurement Software: See section 9 for required capabilities Participating sites may be required to qualify for, and consistently perform at, a specific level of compliance. (See discussion of Bulls-eye Compliance Levels in Appendix C.) Documentation of Acceptable/Target/Ideal Levels of Compliance will appear in relevant sections throughout this document. 2.3. Infrastructure No particular infrastructure or physical environment is specified. It is assumed that imaging procedures will be performed in locations that are in compliance with local regulations for operating medical imaging facilities. 2.4. Quality Control 2.4.1. Procedures See 12.1.1 for procedures the site must document/implement. 2.4.2. Baseline Metrics Submitted Prior to Subject Accrual See 12.1.2 for metric submission requirements. 2.4.3. Metrics Submitted Periodically During the Trial See 12.1.3 for metric submission requirements. Additional task-specific Quality Control is described in sections below. 2.5. Protocol-specific Training No UPICT protocol-specific training is specified beyond familiarity with the relevant sections of this document. 3. Subject Scheduling 3.1. Timing Relative to Index Intervention Activity 3.2. Timing Relative to confounding Activities (to minimize impact) This protocol does not presume any timing relative to other activities. Fasting prior to a contemporaneous FDG PET scan or the administration of oral contrast for abdominal CT are not expected to have any adverse impact on this lung tumor protocol. 3.3. Scheduling Ancillary Testing This protocol does not depend on any ancillary testing. 4. Subject Preparation 4.1. Prior to Arrival No preparation is specified beyond the local standard of care for CT with contrast. 4.2. Upon Arrival 4.2.1. Confirmation of subject compliance with instructions No preparation is specified beyond the local standard of care for CT with contrast. 4.2.2. Ancillary Testing No ancillary testing is specified beyond the local standard of care for CT with contrast. 4.2.3. Preparation for Exam No exam preparation is specified beyond the local standard of care for CT with contrast. 5. Imaging-related Substance Preparation and Administration 5.1. Substance Description and Purpose The use of contrast is not an absolute requirement for this protocol. However, the use of intravenous contrast material is often medically indicated for the diagnosis and staging of lung cancer in many clinical settings. Contrast characteristics influence the appearance and quantification of the tumors; therefore, a given subject must be scanned with the same contrast agent and administration procedures for each scan, even if that means no contrast is given due to it not being given in previous exams of this subject in this trial. A subject should be scanned with the same brand of contrast agent for each scan (Target). Another brand or switch of contrast agent type may be used if medically indicated, e.g., a switch from ionic to non-ionic contrast media (Acceptable). 5.2. Dose Calculation and/or Schedule For a given subject, the same contrast dose should be used for each scan (Target). If a different brand or type of contrast is used, the dose may be adjusted to ensure comparability as indicated and as documented by peer-reviewed literature and/or the contrast manufacturers package inserts (Acceptable). Site-specific sliding scales that have been approved by local medical staffs and regulatory authorities should be used for patients with impaired renal function (e.g., contrast dose Rreduction based on creatinine clearance). 5.3. Timing, Subject Activity Level, and Factors Relevant to Initiation of Image Data Acquisition For a given subject, image acquisition should start at the same time after contrast administration for each scan (Target). Scan delay after contrast administration is dependent upon the both the dose and rate of administration, as well as the type of scanner being used. Contrast administration should be tailored for both the vascular tree as well as optimization of lesion conspicuity in the solid organs. (These guidelines do not refer to perfusion imaging of single tumors.) Generally, since there are multiple concentrations of contrast as well as administration rates and scanning speeds, it is difficult to mandate specific values. Generally, institutional guidelines should be followed so as to optimize reproducibility of the scan technique. 5.4. Administration Route Intravenous. 5.5. Rate, Delay and Related Parameters / Apparatus Contrast may be administered manually (Acceptable), preferably at the same rate for each scan (Target), which is most easily achieved by using a power injector (Ideal). If a different brand or type of contrast is used, the rate may be adjusted to ensure comparability if appropriate and as documented by peer-reviewed literature and/or the contrast manufacturers package inserts (Acceptable). 5.6. Required Visualization / Monitoring, if any No particular visualization or monitoring is specified beyond the local standard of care for CT with contrast. 5.7. Quality Control See 12.2. 6. Individual Subject Imaging-related Quality Control See 12.3. 7. Imaging Procedure 7.1. Required Characteristics of Resulting Data This section describes characteristics of the acquired images that are important to this protocol. Characteristics not covered here are left to the discretion of the participating site. Additional details about the method for acquiring these images are provided in section 7.2. 7.1.1. Data Content These parameters describe what the acquired images should contain/cover. Parameter Compliance Level *  Anatomic Coverage Acceptable entire lung fields, bilaterally (lung apices through bases) Target entire lung fields, bilaterally (lung apices through adrenal glands) Field of View : Pixel Size Acceptable complete thorax : 0.55 to 1.0mm Target rib-to-rib: 0.55 to 0.8mm * See Appendix C for a discussion of Bulls-eye Compliance Levels Field of View affects pixel size due to the fixed image matrix size used by most CT scanners. If it is clinically necessary to expand the field of view to encompass more anatomy, the resulting larger pixels are acceptable. 7.1.2. Data Structure These parameters describe how the data should be organized/sampled. Parameter Compliance Level *  Collimation Width Acceptable 5 to 160mm Target 10 to 80mm Ideal 20 to 40mm Slice Interval Acceptable contiguous or up to 50% overlap Slice Width Acceptable <= 53.0mm Target 1.0 to 2.5mm Ideal <= 1.0mm Pixel Size  see 7.1.1 Isotropic Voxels Acceptable (5:1) slice width <= 5 x pixel size Target (1:1) slice width = pixel Size Scan Plane Acceptable same for each scan of subject Target 0 azimuth Rotation Speed Acceptable manufacturers default * See Appendix C for a discussion of Compliance Level Collimation Width (defined as the total nominal beam width) is often not directly visible in the scanner interface. Wider collimation widths can increase coverage and shorten acquisition, but can introduce cone beam artifacts which may degrade image quality. Slice intervals (a.k.a. "reconstruction intervals" that result in discontiguous data are unacceptable as they may truncate the spatial extent of the tumor, degrade the identification of tumor boundaries, confound the precision of measurement for total tumor volumes, etc. Pitch impacts dose since the area of overlap results in additional dose to the tissue in that area. Overlaps of greater than 20% have insufficient benefit to justify the increased exposure. Slice Width directly affects voxel size along the subject z-axis. Smaller voxels are preferable to reduce partial volume effects and (likely) provide higher precision due to higher spatial resolution. Pixel Size directly affects voxel size along the subject x-axis and y-axis. Smaller voxels are preferable to reduce partial volume effects and (likely) provide higher measurement precision. Isotropic Voxels are expected to improve the reproducibility of tumor volume measurements, since the impact of tumor orientation (which is difficult to control) is reduced by more isotropic voxels. Scan Plane may differ for some subjects due to the need to position for physical deformities or external hardware, but should be constant for each scan of a given subject. Faster Rotation Speed reduces the breath hold requirements and reduces the likelihood of motion artifacts. 7.1.3. Data Quality These parameters describe the quality of the images. Parameter Compliance Level *  Motion Artifact Acceptable minimal (see below) Target no artifact Noise Metric Acceptable std. dev. in 20cm water phantom < 40 HU Target  Ideal  Spatial Resolution Metric Acceptable >= 6 lp/cm Target >= 7 lp/cm Ideal >= 8 lp/cm * See Appendix C for a discussion of Bulls-eye Compliance Levels Motion Artifacts may produce false targets and distort the size of existing targets. Minimal artifacts are such that motion does not degrade the ability of image analysts to detect the boundaries of target lesions. Noise Metrics quantify the level of noise in the image pixel values. Noise metrics are not defined by this UPICT protocol. They are left to the local standard of care for balancing image quality with the risks of increasing radiation exposures. Spatial Resolution Metric quantifies the ability to resolve spatial details. It is stated in terms of the number of line-pairs per cm that can be resolved in a scan of resolution phantom (such as the synthetic model provided by the American College of Radiology and other professional organizations). Lower spatial resolution can make it difficult to accurately determine the borders of tumors, and as a consequence, decreases the precision of volume measurements. Spatial resolution is mostly determined by the scanner geometry (which is not usually under user control) and the reconstruction algorithm (which is under user control). Procedures for measuring and optimizing spatial resolution are not specifically defined by this UPICT protocol, other than to note that higher resolution tends to increase the precision of measurement, and as a consequence, enhance both patient care and scientific merit in clinical trials. 7.2. Imaging Data Acquisition 7.2.1. Subject Positioning For a given subject, they may be placed in a different position if medically unavoidable due to a change in clinical status (Acceptable), but otherwise the same positioning should be used for each scan (Target) and if possible, that should be Supine/Arms Up/Feet First (Ideal). If the previous positioning is unknown, the subject should be positioned Supine/Arms Up/Feet First if possible. This has the advantage of promoting consistency, and reducing cases where intravenous lines, which could introduce artifacts, go through gantry. Subject positioning shall be recorded, manually by the staff (Acceptable) or in the image dataset header (Target). Consistent positioning is required to avoid unnecessary variance in attenuation, changes in gravity induced shape, or changes in anatomical shape due to posture, contortion, etc. Careful attention should be paid to details such as the position of their upper extremities, the anterior-to-posterior curvature of their spines as determined by pillows under their backs or knees, the lateral straightness of their spines, and, if prone, the direction the head is turned. Factors that adversely influence patient positioning or limit their ability to cooperate (breath hold, remaining motionless, etc.) should be recorded in the corresponding DICOM tags and case report forms, e.g., agitation in patients with decreased levels of consciousness, patients with chronic pain syndromes, etc. 7.2.2. Instructions to Subject During Acquisition Breath Hold Subjects should be instructed to hold a single breath at full inspiration (Target) or at least near the high end inspiration (Acceptable) for the duration of the acquisition. Breath holding reduces motion which might degrade the image. Full inspiration inflates the lungs which is necessary to separate structures and make lesions more conspicuous. 7.2.3. Timing/Triggers For each subject, the time-interval between the administration of intravenous contrast and the start of the image acquisition should be determined in advance, and then maintained as precisely as possible during all subsequent examinations. For lung masses, image acquisition should be timed to coincide with visualization of the thoracic arteries. For sub-diaphragmatic acquisitions, timing should coincide with opacification of the portal-venous blood vessels. Acceptable: use a standard time; Target: evaluate manually. 7.2.4. Model-Specific Parameters Appendix G.1 lists acquisition parameter values for specific models/versions that can be expected to produce data meeting the requirements of Section 7.1. 7.2.5. Archival Requirements for Primary Source Imaging Data See 11.3. 7.3. Imaging Data Reconstruction These parameters describe general characteristics of the reconstruction. Parameter Compliance Level *  Reconstruction Kernel Characteristics Acceptable soft to overenhancing Target standard to enhancing Ideal slightly enhancing Reconstruction Interval Acceptable <= 5mm Target <= 3mm Ideal <= 1mm Reconstruction Overlap Acceptable contiguous (e.g., 5mm thick slices, spaced 5mm apart or 1.25mm spaced1.25 mm apart) Target 20% overlap (e.g. 5mm thick slices, spaced 4mm apart or 1.25mm spaced 1mm apart) * See Appendix C for a discussion of Bulls-eye Compliance Levels Reconstruction Kernel Characteristics should be the same for each scan of a given subject. A softer kernel can reduce noise at the expense of spatial resolution. An enhancing kernel can improve resolving power at the expense of increased noise. Moderation on both fronts is recommended with a slight bias towards enhancement. Reconstruction Interval should be the same for each scan of a given subject. Reconstruction Overlap should be the same for each scan of a given subject. Decisions about overlap should consider the technical requirements of the clinical trial, including effects on measurement, throughput, image analysis time, and storage requirements. Reconstructing datasets with overlap will increase the number of images and may slow down throughput, increase reading time and increase storage requirements. It should be noted that for multidetector row CT (MDCT) scanners, creating overlapping image data sets has NO effect on radiation exposure; this is true because multiple reconstructions having different kernel, slice thickness and intervals can be reconstructed from the same acquisition (raw projection data) and therefore no additional radiation exposure is needed. As a consequence, MDCT scanners are the Target scanners for this UPICT protocol, and the more rows of detectors, the closer the acquisition comes to Ideal specifications. 7.3.1. Model-Specific Parameters Appendix G.2 lists reconstruction parameter values for specific models/versions that can be expected to produce data meeting the requirements of Section 7.1. 7.3.2. Archival Requirements for Reconstructed Imaging Data See 11.4. 7.3.3. Quality Control See 12.4. 8. Image Post-processing No post-processing shall be performed on the reconstructed images sent for image analysis. Such processing, if performed, has the potential to disrupt the consistency of the results. 9. Image Analysis Each lung lesion shall be characterized as described in this section. Lesions of interest include: a) small pulmonary nodules surrounded by air; b) small to medium pulmonary nodules surrounded by air and/or with adjacent normal and abnormal (non-neoplastic) anatomic structures; c) large pulmonary masses surrounded by air and/or with adjacent normal and abnormal (non-neoplastic) anatomic structures and/or confluent with mediastinum, chest wall, and diaphragm. Thus, the criteria for selecting large masses as target lesions is dependent on the contrast between neoplastic and non-neoplastic tissue. Fluid, blood, necrotic debris, and the like should not be included in the measurement of tumor volume. Procedures for segmenting tissue types within a mass are not described by this UPICT protocol but should be implemented when technically feasible. 9.1. Input Data to Be Used The reconstructed images may be used directly since no post-processing is specified. No other data is required for this Analysis step. 9.2. Methods to Be Used Each lesion shall be characterized by determining the boundary of the lesion (referred to as segmentation) and taking certain measurements of the segmented lesion. Segmentation may be performed automatically by a software algorithm, manually by a human observer, or semi-automatically by an algorithm working with human guidance/intervention. Measurements may be performed automatically by a software algorithm, manually by a human observer with e-calipers, or semi-automatically by an algorithm working with human guidance/intervention. It is expected that automated boundary detection algorithms will place segmentation edges with greater precision, accuracy and speed than an operator can draw by hand with a pointing device. It is also expected that automated algorithms for finding the Longest Diameter (LD) and Longest Perpendicular (LP) within each ROI will have greater speed and precision of measurement than an operator using electronic calipers. The performance of the algorithms will, however, depend on the characteristics of the lesions may be challenged by complex lung tumors. For each method of segmentation and measurement a site chooses to use, the baseline intra- and inter-rater reliability for segmentation and for linear measurement shall be measured using the methods described in section 9.6. Methods for adjudicating discordant results are not described in this UPICT protocol. Various systems of adjudication are to be selected by attending physicians and clinical trial sponsors or their designees. The intra-rater reliability of fully automated tumor segmentation shall be greater than 80% (Acceptable), preferably greater than 90% (Target), and can be greater than 95% (Ideal). Operator assisted semi-automatic segmentation should produce the same level of intra- and inter-rater reliability for the volume measurements of each target lesion. 9.3. Required Characteristics of Resulting Data While all measurement metrics are proxies for tumor burden, it is still uncertain which measurement metric is optimal for assessing changes in health status. Accordingly, multiple overlapping measurements are specified here. The meta data shall include: For each target lesion, the lesion volume, in mm3 or mL (volumetric metric) which is defined as the sum of all the voxel volumes within the boundaries of a discrete tumor mass on all the tomographic slices on which it is visible. Sum of Target Lesion Volumes: A value computed by adding up all of the target lesion volumes. longest diameter (LD), in mm (uni-dimensional metric) which is defined as the longest continuous, in-plane line-length that can be placed within a non-nodal tumor mass on a transaxial image. The LD should correspond to the greatest distance between two in-plane voxels anywhere in the stack of images on which the mass can be visualized. It is expected that the axial level on which the LD will be derived will vary from time-point to time-point. Short Axis: The short axis is defined as the longest line that is perpendicular to the longest, in-plane line length (see nearby diagram). In contrast to extra-nodal masses, the length of the short-axis is the RECIST 1.1 outcome measure for lymph nodes.  SHAPE \* MERGEFORMAT  Diagram: Illustration showing the long axis and the short axis of a lymph node. the longest perpendicular (LP), in mm (bi-dimensional metric), that is, the longest, in-plane line that can be placed at a 90 degree angle to the LD on the one slice containing the LD for a tumor Sum of the Diameters (SOD): A value computed by adding up all of the longest diameters (LDs) of all of the non-nodal Target Lesions and the Short Axis of each Target lymph node. The following definitions apply to the resulting data: Baseline: The measurements based on the pre-treatment scan set acquired most closely to the start of treatment. Nadir: The lowest value for the sum of the longest diameters or sum of the volumes of all target lesions. In effect, the nadir is the new "baseline equivalent" value for assessing progression. Progressive Disease (PD) is defined as an increase in the sum of the longest diameters by 20% from nadir, if but only if, the new sum of the diameters (SOD) exceeds 5 mm. For volumes, PD is defined as an increase of more than 20% or two times the Standard Deviation of measurement, whichever is greater. Non-Measurable Lesions: Neoplastic masses that, in their longest uninterrupted diameter at baseline, are too small to measure because the greatest distance between any two in-plane pixels is less than two times the axial slice thickness. Non-Target Lesions (NTL): Additional neoplastic masses that meet the criteria of target lesions but are not selected for quantitative assessment, neoplastic masses that either do not meet the minimum size criteria or are not suitable for repeat measurement, and any truly non-measurable lesions, such as bone metastases, leptomeningeal metastases, malignant ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis cutis/pulmonis, cystic lesions, ill defined abdominal masses, etc. Non-target lesions must be followed qualitatively. 9.4. Platform-specific Instructions Appendix G.4 lists parameter values and/or instructions for specific models/versions that can be expected to produce data meeting the requirements of Section 9.3. 9.5. Archival and Distribution Requirements See 11.6. 9.6. Quality Control See 12.6. For all measurements, the coefficients of variation should be characterized, and the 95% confidence interval surrounding them should be calculated. Specific quality assurance procedures for estimating variance are not specified in this UPICT protocol. 10. Image Interpretation While Analysis is primarily about computation; Interpretation is primarily about judgment. Interpretation may be performed at both the lesional / target level and in the aggregate at the subject level (e.g., in an oncology study each index lesion may be measured in longest diameter during the analysis phase, but in this phase a judgment may be made as to whether there is a new non-index lesion; the aggregation of the measured lesions with comparison to previous studies coupled with the judgment as to the presence or absence of a new lesion will result in the RECIST classification at the subject level). 10.1. Input Data to Be Used Describe required input data and any necessary validation or adjustments which should be performed on it. May also specify data which should not be used until after the clinical trial interpretation is recorded. (e.g. particular image series or views; before and after processing versions of images to evaluate/validate the effects of processing; analysis results) 10.2. Methods to Be Used Describe how the interpretation should be performed. (For example, definition of key anatomical points or pathology boundaries; scoring scales and criteria such as BIRADS, interpretation schema such as RECIST, related annotations) 10.3. Required Characteristics of Resulting Data 10.4. Platform-specific Instructions Appendix G.5 provides instructions for specific models/versions that can be expected to produce data meeting the requirements of Section 10.3. 10.5. Reader Training 10.6. Archival Requirements See 11.7. 10.7. Quality Control See 12.7. 11. Archival and Distribution of Data Describe the required data formats, transmission methods, acceptable media, retention periods, (e.g. Is the site required to keep local copies in addition to transmitting to the trial repository? Must all intermediate data be archived, or just final results? At what point may various data be discarded?) 11.1. Central Management of Imaging Data Ideal: electronic transmission of encrypted data over a secure network Target: electronic transmission with a secure file transfer protocol Acceptable: courier shipment of physical media containing electronic copies of the data Note: The submission of films for digitization is rarely acceptable. When digitized films are submitted, they must contain a ruler or quantification will not be possible. Imaging data for analysis at central laboratories should be de-identified according to 11.2. De-identification / Anonymization Schema(s) to Be Used The de-identification software should be certified as fit-for-purpose by regulatory authorities at both the site of origin and site of receipt. All personal patient information that is not needed for achieving the specific aims of the trial should be removed. Pre-specified data, such as height, weight, and in some cases, sex, race, or age, may be retained if it is essential for achieving the specific aims of the study and as such has been approved for use by regulatory authorities. Quality assurance procedures must be performed by the recipient to verify that the images that will be submitted for analysis have been properly de-identified. Acceptable: Data should be transferred to a "quarantine area" of a "safe harbor" for cleaning and certification of de-identification by professional research organizations or trained operators using procedures that have been certified by regulatory authorities at the site of receipt. Quality assurance procedures performed by the recipient should verify that the images that will be submitted for analysis have been properly de-identified. Images that were not properly de-identified prior to receipt by the central archiving facility should be obliterated after assuring that copies conform to quality standards for patient privacy. 11.3. Primary Source Imaging Data This protocol presumes no archiving the pre-reconstruction image data. 11.4. Reconstructed Imaging Data Reconstructed images shall be archived locally, formatted as either DICOM CT image objects or DICOM Enhanced CT image objects. Retention period and policy is left to the Clinical Trial Protocol author. 11.5. Post-Processed Data No post processing is specified, however if post-processing is performed, the images shall be archived the same as 11.4. 11.6. Analysis Results Segmentation results may be recorded as DICOM Segmentation Objects, or STL Model Files. Measurement results may be recorded as The data described in 9.3 may be provided in any of the following formats: DICOM SR DICOM RTSS DICOM secondary capture XLS, CSV, XML 11.7. Interpretation Results 12. Quality Control 12.1. QC Associated with the Site 12.1.1. Quality Control Procedures Describe required procedures and documentation for routine and periodic QC for the site and various pieces of equipment. 12.1.2. Baseline Metrics Submitted Prior to Subject Accrual List required baseline metrics and submission details. 12.1.3. Metrics Submitted Periodically During the Trial List required periodic metrics and submission details. 12.2. QC Associated with Imaging-related Substance Preparation and Administration 12.3. QC Associated with Individual Subject Imaging Acquisition System Calibration Ideal: A protocol specific calibration and QA program shall be designed consistent with the goals of the clinical trial. This program shall include (a) elements to verify that sites are performing the specified protocol correctly, and (b) elements to verify that sites CT scanner(s) is (are) performing within specified calibration values. These may involve additional phantom testing that address issues relating to both radiation dose and image quality (which may include issues relating to water calibration, uniformity, noise, spatial resolution -in the axial plane-, reconstructed slice thickness z-axis resolution, contrast scale, CT number calibration and others). This phantom testing may be done in additional to the QA program defined by the device manufacturer as it evaluates performance that is specific to the goals of the clinical trial. Target: A protocol specific calibration and QA program shall be designed consistent with the goals of the clinical trial. This program may include (a) elements to verify that sites are performing the specified protocol correctly, and (b) elements to verify that sites CT scanner(s) is (are) performing within specified calibration values. These may involve additional phantom testing that address a limited set of issues primarily relating dose and image quality (such as water calibration and uniformity). This phantom testing may be done in additional to the QA program defined by the device manufacturer as it evaluates performance that is specific to the goals of the clinical trial. Acceptable: Site staff shall conform to the QA program defined by the device manufacturer. 12.3.1. Phantom Imaging and/or Calibration [Document the procedure for acquiring images and measuring the image quality metrics in the acquisition protocol description, e.g. uniformity, noise, effective resolution] 12.3.2. Quality Control of the Subject Image and Image Data 12.4. QC Associated with Image Reconstruction 12.5. QC Associated with Image Processing 12.6. QC Associated with Image Analysis 12.7. QC Associated with Interpretation 13. Imaging-associated Risks and Risk Management 13.1. Radiation Dose and Safety Considerations It is recognized that X-ray CT uses ionizing radiation and this poses some small, but non-zero risk to the patients in any clinical trial. The radiation dose to the subjects in any trial should consider the age and disease status (e.g. known disease or screening populations) of these subjects as well as the goals of the clinical trial. These should inform the tradeoffs between desired image quality and radiation dose necessary to achieve the goals of the clinical trial. 13.2. Imaging Agent Dose and Safety Considerations 13.3. Imaging Hardware-specific Safety Considerations 13.4. Management and Reporting of Adverse Events Associated with Imaging Agent and Enhancer Administration 13.5. Management and Reporting of Adverse Events Associated with Image Data Acquisition Appendix A: Acknowledgements and Attributions This imaging protocol is proffered by the Radiological Society of North America (RSNA) Quantitative Imaging Biomarker Alliance (QIBA) Volumetric Computed Tomography (v-CT) Technical Committee. The v-CT technical committee is composed of scientists representing the imaging device manufacturers, image analysis software developers, image analysis laboratories, biopharmaceutical industry, academia, government research organizations, professional societies, and regulatory agencies, among others. All work is classified as pre-competitive. A more detailed description of the v-CT group and its work can be found at the following web link:  HYPERLINK "http://qibawiki.rsna.org/index.php?title=Volumetric_CT" http://qibawiki.rsna.org/index.php?title=Volumetric_CT The Volumetric CT Technical Committee (in alphabetical order): Avila, R Kitware, Inc. Buckler, A (Chair) Buckler Biomedical LLC Dorfman, G (UPICT liaison) Cornell Fenimore, C (WG 1C leader) Nat Inst Standards & Technology Ford, R RadPharm, Inc. Gottlieb, R Roswell Park Cancer Center Hayes, W Bristol Myers Squibb Hillman, B Metrix, Inc. McNitt-Gray, M University California Los Angeles Mozley, PD (pharma industry co-chair) Merck & Co Inc/PhRMA Mulshine, JL Rush Nicholson, D Definiens, Inc. O'Donnell, K (IHE liaison) Toshiba Petrick, N (WG 1A leader) US Food and Drug Administration Schwartz, LH (academic co-chair) Sullivan, DC (RSNA Executive Sponsor) Duke University Zhao, B., Memorial Sloan Kettering Cancer Center The v-CT Committee is deeply grateful for the remarkable support and technical assistance provided by the staff of the Radiological Society of North America, including Susan Anderson, Linda Bresolin, Joseph Koudelik, and Fiona Miller. Appendix B: Background Information The long-term goal of the v-CT committee is to qualify the quantification of anatomical structures with x-ray computed tomography (CT) as biomarkers. The v-CT group selected solid tumors of the chest in patients with lung cancer as its first case-in-point. The rationale for selecting lung cancer as a prototype is that the systems engineering analysis, the groundwork, profile claims documents, and roadmaps for biomarker qualification in this specific setting can serve as a general paradigm for eventually quantifying volumes in other structures and other diseases. The specific aim of this image acquisition and processing protocol is to describe procedures that seem sufficient for quantifying the volumes of neoplastic masses in the chest that have relatively simple geometric shapes and are adequately demarcated from surrounding non-neoplastic tissues. This particular image acquisition and processing protocol is limited to masses that have measurable diameters of 10 mm or more. The profile claims document on which this protocol is based asserts that following these image acquisition and processing procedures will produce volume measures with less than 18% test-retest variability. The protocol describes, in predominantly chronological order, procedures that are required to achieve this level of precision. The protocol describes procedures that should be universally followed in this setting, regardless of the instrument that is used to acquire the data. It also provides links to tables that list specific settings on various makes-and-models of CT scanners. This protocol should be considered for use in the care of individual patients in conventional medical settings, as well as in clinical trials of new therapies for lung cancer. Table 1 summarizes how staging relates to lung cancer drug therapy approaches, the imaging approaches used in those stages and issues relative to the image requirements. Table 1: Summary of Image Processing Issues Relative to Stage of Lung Cancer Stage % of Cases 5-year Survival % Imaging Focus / Therapy Focus Imaging Tool Issues Thoracic Segment. Hi-Res I 16% 49% Primary tumor / Neo and adjuvant RX sCT Small cancers surrounded by air Can be straight forward Need II / III 35% 15.2% Primary, hilar and mediastinal lymph nodes / Combined modality sCT, PET Larger tumors and nodes abut other structures Often challenging Opt. IV 41% 3% Primary/regional nodes and metastatic sites / Chemotherapy sCT, PET, Bone, Brain Scan Tumor response often determined outside the chest Often challenging Opt.  Appendix C: Conventions and Definitions Bulls-eye Compliance Levels Acquisition parameter values and some other requirements in this protocol are specified using a bullseye approach. Three rings are considered from widest to narrowest with the following semantics: ACCEPTABLE: failing to meet this specification will result in data that is likely unacceptable for the intended use of this protocol. TARGET: meeting this specification is considered to be achievable with reasonable effort and equipment and is expected to provide better results than meeting the ACCEPTABLE specification. IDEAL: meeting this specification may require unusual effort or equipment, but is expected to provide better results than meeting the TARGET. An ACCEPTABLE value will always be provided for a specified parameter. When there is no reason to expect better results (e.g. in terms of higher image quality, greater consistency, lower dose, etc.), TARGET and IDEAL values are not provided. Some protocols may need sites that perform at higher compliance levels do so consistently, so sites may be requested to declare their level of compliance. If a site declares they will operate at the TARGET level, they must achieve the TARGET specification whenever it is provided and the ACCEPTABLE specification when a TARGET specification is not provided. Similarly, if they declare IDEAL, they must achieve the IDEAL specification whenever it is provided, the TARGET specification Acquisition vs. Analysis vs. Interpretation This document organizes acquisition, reconstruction, post-processing, analysis and interpretation as steps in a pipeline that transforms data to information to knowledge. Acquisition, reconstruction and post-processing are considered to address the collection and structuring of new data from the subject. Analysis is primarily considered to be computational steps that transform the data into information, extracting important values. Interpretation is primarily considered to be judgment that transforms the information into knowledge. (The transformation of knowledge into wisdom is beyond the scope of this document.) Other Definitions AnonymizationAnonymization is the process of de-identification and further removal or amiguation of information to reduce the probability of re-identification of the image despite access to other information sourcesAdjudication or Adjudication ReadAdjudication is the processes of decision making that involves an independent party with the authority to determine a binding resolution through a prespecified process. In the standard read design once a primary analysis of all time point data for each patient has been completed, the findings are compared in order to identify any discrepancies in overall assessments of Best Overall Response, Date of Progression, Date of Response and Date of Response Confirmation. So as to ascertain the final determination for discrepant cases, a third Reviewer will review the patient data and choose to agree with the findings of one of the two prior analyses. The third Reviewer evaluates the same set of images used by Reviewers 1 and 2 and will not have seen the images before. A variation of this read design is to have a third Reviewer who is blinded to the previous findings and reviews the cases in exactly the same fashion as the initial Reviewers. If agreement is not reached in three separate analyses, a consensus of Reviewers is required in order to verify the final determination for that patient. Read designs will be outlined in detail in the Independent Review Charter in advance of eCRF design, or Adjudication is a means of deciding an outcome where two different opinions are formed, or Generally referring to a blinded independent read designed to resolve discrepancies between two primary readers.Adjudication RateThe Adjudication Rate is the number of cases that are adjudicated divided by the total number of cases evaluated. Baseline Followed by Randomized Temporal Image Presentation Baseline Followed by Randomized Temporal Image Presentation is the sequence of image presentation such that the baseline (earliest) time point is shown to the reviewer for the purpose of identifying regions of interest, such as selecting neoplastic masses as target lesions. Subsequent time points are presented in a random order with respect to the date.BlindingBlinding is a procedure in which one or more parties to the trial are kept unaware of the treatment assignments and other information that might introduce bias. Single blinding usually refers to the subjects being unaware, and double-blinding usually refers to the subjects, investigators, monitor, and, in some cases, data analysts being unaware of the treatment assignments, or Blinding is the outcome of all processes and procedures that are deployed to prevent image analysis operators or reviewers from becoming aware of or informed about the circumstances surrounding a case, such as the information in the following abbreviated list investigational (test diagnostic or test therapeutic) arm (or any data that might reveal the investigational arm) subject demographics site assessments (including site choice of lesions) situational specific descriptions of the scans (such as confirmation or end of treatment scans) results or assessments of other reviewers participating in the reading process (except during some adjudication scenarios) clinical data other than that which has been pre-specified described in the imaging charter. Blinded ReadA Blinded Read is the analysis of images to determine results of the testing in which the radiologist is unaware of any subject or site information.Burned-in InformationBurned-in Information is information that is part of the actual pixel data as opposed to present in the image header. CommentA comment in this instance is generally referring to a text field that can capture additional reader insight into the read process or reader thought processes. Comments are generally required when the reader indicates an image in Not Evaluable or their opinion differs from the derived response.Clinical Read or Site readGenerally referring to an independent read that combines the result of the imaging review with pre-defined clinical information to come to a final outcome associated with the efficacy endpoint. Readers are generally blind to treatment groups but may be provided a variety of clinical information appropriate to the disease assessment. Or Image interpretation done at the investigational siteComputer Generated Quantitative Image AnalysisComputer Generated Quantitative Image Analysis is an analysis performed automatically by a computer with little or no human interaction using signal processing algorithms to quantify an imaging outcome measure. This type of analysis should be deterministic (always produce identical output from the same input) or have low variability. Clinical DataConfirmation ReadA Confirmation Read is generally referring to a central read that occurs based on an on-site event. Confirmation reads are associated with eligibility criteria, disease progression or other events that may benefit from a third party confirmation.  Data LockThe Data Lock is the point and method when the results of an assessment or imaging outcome variable are considered final and are protected. This must be pre-defined in the analysis. Locking must not be construed to mean an assessment cannot be overturned as indicated by emerging data as long as: (1) the process is pre-defined in the Imaging Charter; (2) the process is driven by data that, by design, emerges after the initial assessment; and (3) there are adequate audit trails that can substantiate the changes. De-identificationDe-identification is the process of removing real patient identifiers or the removal of all subject demographics from imaging data for anonymizationDe-personalizationDe-personalization is the process of completely removing any subject-related information from an image, including clinical trial identifiers.Derived ResponseA Derived Response is an outcome measure algorithmically derived based on information from the blinded reader assessments.End of Review Data LockIn the End of Review Data Lock, the data are locked when the reviews of all the time points for the subject have been completed.EvaluableGenerally referring to image quality. Based on presence or absence of necessary imaging and the associate image quality. Evaluable is the response generated when an image and/or time point can be interpreted.Exam Level Data LockIn the Exam Level Data Lock, the data are "locked" in "final form" after each Exam (medical imaging procedure) is assessed. The purpose of the Exam Lock is to assess the differential contribution of each Exam to the overall assessment. Human Interfaced Image AnalysisHuman Interfaced Image Analysis is image analysis that is driven primarily by a human reviewer who may use computer generated analysis tools to quantify an imaging outcome measure. Hybrid Randomized Image PresentationHybrid Randomized Image Presentation. In this paradigm, the first stage of the assessment is fully randomized or the post-baseline scans are randomized. Once the results have been locked for each time point, the images are re-presented in known chronological order for reconsideration. Changes in any of the randomized assessments are tracked and highlighted in the final assessment. In within-patient-control trials (e.g. comparative imaging) images obtained before and after the test agent should be presented in randomized un-paired fashion. The minimum size of the randomization block necessary to minimize recall should be considered.Image Analysis, Image Review, and/or ReadProcedures and processes that culminate in the generation of imaging outcome measures, such as brain volume, cardiac output, or tumor response criteria. Reviews can be performed for eligibility, safety or efficacy. The review paradigm may be context specific and dependent on the specific aims of a trial, the imaging technologies in play, and the stage of drug development, among other parameters. Imaging DataImaging Data are variables derived from the image review or, Imaging Data are quantitative or qualitative variables resulting from image review. Such variables may be used to assess eligibility for study and treatment response, or Imaging Data is information that results from or is produced by the image analysis or review processes (such as lesion selection and their associated spatial measurements), or from algorithmically derived assessments specified in the protocol. In this context, the term also refers to "marks" placed on images, such as regions of interest boundaries, annotations such as "Target Lesion 4", etc.Imaging Endpoint Endpoint based on objective image features chosen to evaluate the activity of a study treatment (e.g. retardation of joint destruction in patients with rheumatoid arthritis) Imaging Examination or Imaging Exam or Exam An Examination or Exam is a single set of intimately related images acquired contemporaneously with a single technology, such as a CT scan of the chest, a whole body bone scintigram, or an echocardiogram. Image HeaderThe Image Header is that part of the file or dataset containing the image other than the pixel data itself Imaging Case Report Forms: Imaging Case Report Forms are IRC-specific forms designed to capture elements of image acquisition, and/or image interpretation and/or derived responses for enrollment and/or eligibility review and/or confirmation reads and/or efficacy assessment.Imaging PhantomsDevices used for periodic testing and standardization of image acquisition. This testing must be site specific and equipment specific and conducted prior to the beginning of a trial (baseline), periodically during the trial and at the end of the trial., Image Review Plan or Radiology Technical ManualThe Image Review Plan or Radiology Technical Manual is a that document that summarizes the plan for the acquisition of imaging data.Imaging Surrogate EndpointImaging endpoint that is correlated with a clinical outcome but is not sufficient to show clinical benefitIndependent ReviewUse definitions in GFI Developing Med Imaging Drug Part 3 2004Independent Review Charter (IRC):The Image Review Charter is a document submitted to a regulatory agency to document and support the use of imaging to support an IND, NDA or BLA. The document identifies and lists imaging resources, imaging surrogate criteria, processes for receipt, handling, preparation and archive of images, the process steps for review and assessment of images and the various methodologies for quality assurance and quality control, or The Image Review Charter is a detailed technical document governing the acquisition, processing, display, interpretation, transfer, and integrity of imaging data in efficacy trials that use imaging for assessment of efficacy outcomes. IRCs are an integral component of the clinical trial protocol and promote quality and verifiability of imaging data. The IRC is designed for use by the clinical investigators, by the central image laboratory and by regulatory agencies. The IRC might be submitted to a regulatory agency for review and comment and to reach agreement on the use of imaging in trials intended to support an NDA or BLA. The IRC contains a summary of the clinical protocol including study design, study population, efficacy endpoints and primary efficacy analysis. The IRC describes imaging resources, processes for receipt, handling, preparation and archive of images, process steps for review and assessment of images and various methodologies for quality assurance and quality control. The IRC needs to cross reference relevant portions of the clinical protocol including enrollment criteria, outcome measures, and statistical analysis plan (including primary efficacy analysis, procedures for handling missing or uninterpretable data etc.) For ease of regulatory review the IRC should include a protocol synopsis that is sufficiently detailed to permit verification of consistency of the IRC with the clinical protocol and statistical analysis plan.Individually Identifiable InformationIndividually Identifiable Information is data that alone or in combination may be used to identify an individual.InterpretableGenerally referring to image quality assessed by the blinded reader. Based on presence or absence of necessary imaging and the associate image quality. Grounds for the assessment are commonly captured. For example, not Optimal but Evaluable is the response generated when an image and/or time point is of questionable quality but can be interpreted.Intra-Observer Variability or Intra-Reader VariabilityIntra-Observer Variability or Intra-Reader Variability is the variability in the interpretation of a set of images by the same reader after an adequate period of time inserted to reduce recall bias. Inter-Observer Variability or Inter-Reader VariabilityInter-Observer Variability or Inter-Reader Variability is the variability in the interpretation of a set of images by the different readers. Not EvaluableGenerally referring to image quality. Based on presence or absence of necessary imaging and the associate image quality. Not Evaluable is the response generated when an image and/or time point cannot be interpreted. May be assessed in real time by a blinded third party quality assessor independently of image reader. Provision for reimaging (where feasible) should be prespecified. Listing of criteria is provided and responses are captured in the CRF.N Time Point Data Lock In the N Time Point Data Lock, a variable number of time points N can be combined and shown together at a particular stage of the review process. For example, the baseline/screening and the first subsequent time point after baseline/screening may be reviewed together to establish the baseline extent of disease.Off-Protocol Imaging Off-Protocol imaging is imaging that may have been performed during a trial and should not be reviewed by the IRC or Imaging which is done during a trial but not required by the protocol.On-Protocol Imaging On-Protocol imaging is imaging that is performed during a trial as required by and defined in the protocol, or On-Protocol imaging is imaging that is performed during a trial as required by and defined in the protocol that should be reviewed by the IRC.Order of Image Presentation The Order of Image Presentation is the sequence that images are presented to reviewers for formal review and generation of the imaging outcome measures. Sufficiently well established designs include:Personal informationPersonal information is data related to person identification - see EU guidance (e.g., Age)Primary Read or Primary ReviewA Primary Read is the blinded review of imaging data in which one or more independent reviewers review images to generate the outcome information associated with the efficacy endpoint, or A Primary Review is the blinded review of data in which one or more independent reviewers review the data to generate the outcome information associated with the efficacy endpoint.PseudonymizationPseudonymization is the process of de-identification and replacement of identifiers with a pseudonym that is unique to the individual and known within the context of a trial but not linked to the individual in the external world.Randomized Independent Temporal Image PresentationRandomized Independent Temporal Image Presentation is the sequence of image presentation that each time point is presented alone, in a random order with respect to the date of acquisition, and reviewed independently without access to other time points.Reader IndependenceAcademic, financial, trial conductScheduled imaging or Scheduled Imaging Assessment Scheduled imaging is imaging that is performed during a trial at one or more of the time points (or window assigned to a time point) designated for imaging assessment in the protocol. Applies to either on-protocol or off-protocol imaging, or Exams that are scheduled as routine assessments.Secondary ReadA Secondary Read is a blinded review of imaging data in which one or more independent reviewers review images to generate outcome data that is not part of the efficacy endpoints. An example would be a read that is part of Intra-reader analysis. Sensitive Personal InformationSensitive Personal Information is data related to personal preferences and disposition. - see EU guidance (e.g., Ethnicity).Sequential Chronologic Image PresentationSequential Chronologic Image Presentation is the sequence of image presentation that images are shown to the reviewer in the order in which they were actually acquired. In this format, the reviewer should not know the total number of time points to be assessed unless that information has been pre-specified in the imaging charter. (For example, pre-specification is usual and customary in imaging studies of neurodegenerative disorders, arthritis, osteoporosis, and congestive heart failure, among others.) Simultaneous Chronological Image PresentationSimultaneous Chronological Image Presentation is the sequence of image presentation that all images associated with a subject are shown to the reviewer at the same time without blinding the date or sequence or total number.Simultaneous Randomized Temporal Image PresentationSimultaneous Randomized Temporal Image Presentation is the sequence of image presentation that all images associated with a subject are shown to the reviewer at the same time in a random order with respect to the date but without blinding to total number.Sequential UnblindingSequential Unblinding Sequential interpretation of images with and without clinical information (e.g. demography, clinical assessments).Statistical Analysis Plan for Medical ImagingAnalysis plan focused on primary efficacy analysis and including statement of null hypothesis, study power, statistical test, efficacy population, and handling of missing or uninterpretable images, sensitivity analysesTime PointA Time Point is a discrete period during the course of a clinical trial when groups of imaging exams or clinical exams are scheduled as defined in the study protocol.Time Point Data Lock In the Time Point Data Lock, the data are locked after all of the pre-specified information associated with each time point is assessed. In some paradigms, the time points are known to be presented in chronological order; in others, the time points may be randomized during the early stages of the image analysis process (vida infra).Truth StandardSingle or multiple image modalitiesUnique Identifiers (UIDs):Unique Identifiers (UIDs) are globally unique identifier used to identifiers images, sets of images, or components within an image.UninterpretableGenerally referring to image quality assessed by the blinded reader.Unscheduled ImagingUnscheduled imaging is imaging that is performed during a trial at a time/date outside the window assigned to a time point designated for imaging assessment in the protocol. It may be ad hoc imaging performed to evaluate an unscheduled clinical circumstance. It may be on-protocol or off-protocol imaging. Appendix D: Documents included in the imaging protocol (e.g., CRFs) Attached. Appendix E: Associated Documents (derived from the imaging protocol or supportive of the imaging protocol) Attached. Appendix F: TBD Appendix G: Model-specific Instructions and Parameters The following sections provide instructions for various equipment models/versions that are expected to produce data meeting the requirements of the relevant activity. The presence of specific product models/versions in the following tables should not be taken to imply that those products are fully compliant with the QIBA Profile. Compliance with a profile involves meeting a variety of requirements of which operating by these parameters is just one. To determine if a product (and a specific model/version of that product) is compliant, please refer to the QIBA Conformance Document for that product. G.1. Image Acquisition Parameters The following technique tables list acquisition parameter values for specific models/versions that can be expected to produce data meeting the requirements of Section 7.1. These technique tables may have been prepared by the submitter of this imaging protocol document, the clinical trial organizer, the vendor of the equipment, and/or some other source. (Consequently, a given model/version may appear in more than one table.) The source is listed at the top of each table. Sites using models listed here are encouraged to consider using these parameters for both simplicity and consistency. Sites using models not listed here may be able to devise their own acquisition parameters that result in data meeting the requirements of Section 7.1 and conform to the considerations in Section 13. In some cases, parameter sets may be available as an electronic file for direct implementation on the imaging platform. Table G.1a Generic: This represents parameters for a generic CT. Source: QIBA v-CT Cmte Date: 2009-mm-dd Parameter Compliance Level* Generic kVp Acceptable 110 to 140  Target 110 to 130  mAs (medium patient) Acceptable 40 to 350  Target 80 to 160   Scan Duration Acceptable < 30 sec.  Target < 15 sec.  Ideal < 10 sec.  Table Speed Acceptable   Target   * See Appendix C for a discussion of the Levels of Compliance kVp and mAs should be adjusted as necessary, depending on the body habitus of individual patients. The values should be consistent for all scans of the same patient. Scan Duration values are intended to allow completion of the scan in a single breath hold for most/a majority/nearly all subjects respectively. Table Speed values are intended to yield an IEC Pitch Value of approximately 1 while achieving the corresponding Scan Duration. Table G.1b: "Target" Compliant Protocols for Specific Systems The following table provides sample parameters sets that meet the Target Level of Compliance for specific models. See Appendix C for a discussion of the Levels of Compliance. Parameters vCT 1A (Philips) GE ACRIN MxIDT 8000 (Thin) MxIDT 8000 (Thick) Ultra VCT-64 6678 Data Content      Anatomic Coverage      Field of View : Pixel Size     Rib-to-rib: 0.55-.75mm Data Structure      Collimation Width 16x0.75 mm 16x1.5 mm   (TBA) Slice Interval      Slice Width 0.8 mm 5.0 mm   1.0 mm Pixel Size     0.55 mm Isotropic Voxels     (2:1) Scan Plane      Rotation Speed     0.5 sec Data Quality      Motion Artifact      Noise Metric      Spatial Resolution Metric      Acquisition      Tube Voltage 120 kVp 120 kVp   120 kVp Exposure 100 mAs 100 mAs   100 mAs Pitch 1.2 1.2    Reconstruction      Recon. Kernel Detailed filter Detailed filter   Standard Recon. Interval      Recon. Overlap 50% 50%   20%        G.2. Image Reconstruction Parameters See above. G.3. Post-Processing Instructions None provided. G.4. Analysis Instructions None provided. G.5. Interpretation Instructions None provided.     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