TABLE 1.

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