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FDG-PET/CT Draft Template - 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