High-Level Outline of Profile
| Item | Details |
|---|---|
| Executive summary | |
| Overview | |
| Summary for clinical trial use | |
| Intended audiences | |
| Clinical context and claims | |
| Claim | |
| Considerations for claim | |
| Clinical trial use | |
| Profile activities | |
| Subject handling | |
| Image data acquisition | |
| Image data reconstruction and postprocessing | |
| Image analysis | |
| Image interpretation and reporting | |
| Quality control | |
| Conformance procedures | Image acquisition site |
| PET acquisition device | |
| Reconstruction software | |
| Image analysis workstation | |
| Software version tracking | |
| References | |
| Appendices |