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QIBA Profile. 18F-Labeled PET Tracers Targeting Amyloid As an Imaging Biomarker

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QIBA Profile. 18F-Labeled PET Tracers Targeting Amyloid As an Imaging Biomarker QIBA Profile Format 20140221 1 2 18 3 QIBA Profile. F-labeled PET tracers targeting 4 Amyloid as an Imaging Biomarker 5 Version with PUBLIC COMMENTS considered 6 02May2018 7 Document generated by .\Profile Editor\ProfileTemplate.sps Page: 1 QIBA Profile Format 20140221 8 Table of Contents 9 1. Executive Summary ................................................................................................................................... 5 10 1.1 Overview ............................................................................................................................................ 5 11 1.2 Summary for Clinical Trial Use ............................................................................................................. 6 12 1.3 Intended Audiences ............................................................................................................................ 6 13 2. Clinical Context and Claims ........................................................................................................................ 7 14 2.1. Claim .................................................................................................................................................. 7 15 2.2. Considerations for claim ..................................................................................................................... 7 16 2.3. Clinical Trial Utilization........................................................................................................................ 8 17 3. Profile Activities ....................................................................................................................................... 12 18 3.1. Subject Handling ............................................................................................................................... 13 19 3.2. Image Data Acquisition ..................................................................................................................... 18 20 3.3. Imaging Data Reconstruction and Post-Processing ............................................................................ 24 21 3.4. Image Analysis .................................................................................................................................. 29 22 3.5. Image Interpretation and Reporting ................................................................................................. 39 23 3.6. Quality Control ................................................................................................................................. 40 24 4. Conformance Procedures ........................................................................................................................ 49 25 4.1. Performance Assessment: Image Acquisition Site ............................................................................ 49 26 4.2. Performance Assessment: PET Acquisition Device............................................................................ 50 27 4.3. Performance Assessment: Reconstruction Software ........................................................................ 56 28 4.3. Performance Assessment: Image Analysis Workstation ................................................................... 58 29 4.3. Performance Assessment: Software Version Tracking ...................................................................... 61 30 References .................................................................................................................................................. 62 31 Appendices.................................................................................................................................................. 69 32 Appendix A: Acknowledgements and Attributions ................................................................................... 69 33 Appendix B: Background Information for Claim ....................................................................................... 71 34 Appendix C: Conventions and Definitions ................................................................................................ 73 35 Appendix D: Model-specific Instructions and Parameters ........................................................................ 78 36 Appendix E: Data fields to be recorded in the Common Data Format Mechanism ................................... 81 37 Appendix F: Testing PET Display and Analysis Systems with the UW-PET QIBA Amyloid Digital Reference 38 Object (DRO) Series ................................................................................................................................. 82 39 Appendix G: Best Practice Guidance for the Hoffman Brain Phantom ...................................................... 86 40 Appendix H: Detailed Example of Hoffman Phantom Data Analysis ......................................................... 88 Document generated by .\Profile Editor\ProfileTemplate.sps Page: 2 QIBA Profile Format 20140221 41 Method Overview .................................................................................................................................... 89 42 Relevant Data Files .................................................................................................................................. 89 43 Appendix I: Kinetic Modeling and Comparison to SUVR ........................................................................ 106 44 45 Document generated by .\Profile Editor\ProfileTemplate.sps Page: 3 QIBA Profile Format 20140221 46 Open Issues: 47 This version incorporates text to address public comments received in response to the version of the Profile 48 dated June 2017. 49 Modifications to address public comments Modifications have been incorporated to address public comment and issues that were outstanding, including the Claim(s). These are subject to additional review. Conformance Methodology The methodology to perform conformance testing of the image analysis workstation is included; this relies upon using a Digital Reference Object (DRO), which is in the process of being completed, funded as a NIBIB groundwork project. Conformance Testing Need to describe a study that actors need to perform to test that: 1) Their wCV is within the parameter stated in the Claim, 2) the wCV is constant over a prescribed range of SUVRs, and 3) linearity with a slope of one is a reasonable assumption. 50 51 Document generated by .\Profile Editor\ProfileTemplate.sps Page: 4 QIBA Profile Format 20140221 52 53 1. Executive Summary 54 1.1 Overview 55 This QIBA Profile documents specifications and requirements to provide comparability and consistency for 56 the use of PET imaging using 18F labeled tracers that bind to fibrillar amyloid in the brain. Quantitative 57 measurement of amyloid, a hallmark pathology of Alzheimer’s disease, has become increasingly used in 58 clinical trials for patient inclusion, evaluation of disease progression, and assessment of treatment effects. 59 The Profile focuses on the use of Standardized Uptake Value Ratios (SUVRs) to measure amyloid burden, 60 while also describing benefits associated with the Distribution Volume Ratio (DVR) (kinetic modeling) 61 approach. The SUVR is determined using data acquired during a time window following a certain time 62 period after tracer injection that is intended to allow the tracer to reach “pseudo” equilibrium. This 63 approach has practical advantages, particularly for multi-site studies, due to the reduced time required for 64 the patient to be in the scanner (and for older scanners, the lesser amount of data acquired for a single 65 scan). 66 The guidance in this Profile can be applied for clinical trial use as well as individual patient management. 67 The document primarily addresses PET/CT imaging; however, a dedicated PET that has transmission 68 capabilities can also be used. PET/MR scanners are not strictly excluded in this version as long as the 69 repeatability of the SUVRs from these scanners is conformant with the assumptions underlying the claims. 70 This Profile, developed through the efforts of the amyloid Profile writing group in the QIBA Nuclear 71 Medicine Technical Subcommittee, shares some content with the QIBA FDG-PET Profile, and includes 72 additional material focused on the devices and processes used to acquire and analyze amyloid tracer PET 73 data. The Profile is organized as follows: 74 75 Figure 1: Illustration of the Profile components 76 The Profile Part 3 is derived from multiple sources, including material contained in the work performed by 77 the Alzheimer’s Disease Neuroimaging Initiative (ADNI). The current version of the Profile focuses on a 78 longitudinal Claim, where the primary purpose is to assess change in amyloid load due to disease or Document generated by .\Profile Editor\ProfileTemplate.sps Page: 5 QIBA Profile Format 20140221 79 following an intervention. In this case, precision is most important as long as bias remains constant over 80 time. Characterization of measurement bias will be important for a cross-sectional Claim wherein the 81 amyloid tracer is used primarily to select amyloid positive subjects. 82 1.2 Summary for Clinical Trial Use 83 The QIBA Amyloid-PET Profile defines the technical and behavioral performance levels and quality control 84 specifications for brain amyloid tracer PET scans used in single- and multi-center clinical trials of neurologic 85 disease, particularly Alzheimer’s disease. Examples of clinical application are detailed below in the Claims. 86 The
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