UPICT TEST SITE - Modified
FDG-PET/CT draft template GSD, June 29, 2009
FYI: The complete draft of the QIBA FDG-PET/CT Whole Body protocol is posted at http://qibawiki.rsna.org/index.php?title=Profile:_FDG-PET_Whole_Body
1. Executive Summary, Introduction and Background Information
- 1.1. Principle
- 1.2. Indications
- 1.3. Relationship with other diagnostic methods
- 1.4. Covariates (note – please see full FDG-PET document; should this material be in other sections of the document?)
2. Claims (what users will be able to achieve)
- 2.1 Claim #1:
- 2.2. Claim #2:
- 2.3. Claim #3:
- 2.4. Claim #4:
- 2.5. Claim #5: (etc.)
3. Imaging Protocol: Overview 3.1. Detail: Utilities and Endpoints of the Imaging Protocol within the Clinical Trial 3.2. Detail: Management of Pre-enrollment Imaging Tests 3.3. Detail: Timing of Imaging Tests within the Clinical Trial Calendar 3.4. Detail: Management of On-protocol Imaging Performed Off-schedule 3.5. Detail: Management of Off-protocol Imaging 3.6. Detail: Subject Selection Criteria Related to Imaging (mainly exclusionary in nature) 4. Subject Preparation 4.1. Detail: Interval Timing (e.g., oral and/or IV intake, vigorous physical activity, timing relative to non-protocol-related medical interventions, etc.) 4.2. Detail: Specific Pre-imaging Instructions 4.3. Detail: Prior to Arrival 4.4. Detail: Upon Arrival (including ancillary testing associated with the imaging and downstream actions relative to such testing) 5. Imaging Procedures: General 5.1. Detail: Data that should accompany the request for a PET study 5.2. Detail: Imaging Agent Preparation and Specification (Contrast agent or radiopharmaceutical) 5.3. Detail: Contrast administration: (agent, dose, route) 5.4. Detail: Procedure for performing the PET study 5.5. Detail: Protocol alterations permitted in the case of multi-centre studies 5.6. Detail: Imaging Data Acquisition 5.7. Detail: Subject Positioning 5.8. Detail: Instructions to Subject during Acquisition (e.g., breathing) 5.9. Detail: Timing (e.g., relative to previously administered imaging agents / enhancers; inter-time point standardization) 6. Reconstruction and Reporting 6.1. Detail: Reconstruction 6.2. Detail: Reporting 6.3. Detail: Interpretation and pitfalls 7. Archival Requirements for Primary Source Imaging Data 7.1. Detail: Data should be archived in DICOM 3.0 format or the current version of DICOM recommended by XXX WG YY of the XXX. 7.2. Detail: De-identification / Anonymization Schema(s) to Be Used 7.3. Detail: Archival and Transmission of Image Data 7.4. Detail: Transmission of Imaging Data from Sites to Central Archive 7.5. Detail: Requirements for Local Retention of Imaging Data 7.6. Detail: Requirements for Central Management of Imaging Data and Imaging Metadata (e.g., the results of image analysis) 8. Post-processing (i.e., anything not done on an acquisition platform that affects DICOM image data and/or pixel / voxel values) None prior to importation into free standing image analysis software package 9. Interpretation 9.1. Detail: Image quality assessment to confirm correctness and completeness of image submission 9.2. Detail: Volume of interest (VOI) Definition 9.3. Detail: Timepoint exams defined by charter re: exam types and dates of inclusion 9.4. Detail: @Open next timepoint for given subject 10. Radiation Dose and Safety Considerations 11. Quality Control 11.1. Detail: General 11.2. Detail: Quality Control and Inter-institution Cross-Calibration 12. Required Documentation 12.1. Detail: Subject preparation 12.2. Detail: Imaging agent dose calculation 12.3. Detail: Imaging agent-related 12.4. Detail: Image data acquisition-related 12.5. Detail: Inherent image data reconstruction / processing 12.6. Detail: Image analysis and interpretation 12.7. Detail: Site selection and Quality Control 13. Acknowledgements