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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 Parameter Entity/actor Specification PET scanner calibration Technologist Must perform daily/weekly/monthly scanner quality assurance and vendor-recommended maintenance procedures (e.g., replace weak transmission sources for dedicated PET scanner); must ensure that output values are acceptable and manually entered on form/electronic database PET scanner calibration constancy check Technologist Must perform constancy phantom (e.g., 68Ge cylinder) scan (preferably NIST-traceable or equivalent to gather information on uniformity as well) at least weekly and after each calibration Radionuclide calibrator Physicist Must be calibrated to 18F using NIST-traceable source or equivalent either by site or by calibrator manufacturer NIST = National Institute of Standards and Technology.
Only shaded rows are mandatory for profile conformance; white row is recommended and may be mandatory in future profile updates.
- TABLE 3.
List of 18F-Amyloid Radiopharmaceuticals and Their Recommended Doses, Uptake Times, and Acquisition Durations
Parameter Florbetapir* Flutemetamol† Florbetaben‡ NAV4694 (80) Administered activity (MBq) 370 (maximum, 50-μg mass dose) 185 (maximum, 20-μg mass dose) 300 (maximum, 30-μg mass dose) 300 Uptake time (postinjection min) 30–50 90 45–130 50–70 Acquisition duration (min) 10 20 15–20 20 Actor Profile section for reference ADNI 2 (58) Site administrator 3.6.1.1: site accreditation/qualification maintenance Same Site administrator 3.6.2: imaging facility personnel Same Medical physicist 3.6.3: amyloid PET acquisition scanner Same Medical physicist 3.6.3.1.1: radionuclide calibrator Same Medical physicist 3.6.3.1.2: scales and stadiometers Not required Medical physicist 3.6.3.1.4: clocks and timing devices Not required Medical physicist 3.6.4.1: uniformity and calibration Not required Medical physicist 3.6.4.2: resolution Same Medical physicist 3.6.4.3: noise Same Medical physicist 3.6.4.4: amyloid PET specific phantom measurements Same Medical physicist 4.1: performance assessment: image acquisition site Same Technologist 3.1.3.1.2: radiopharmaceutical activity calculation or schedule Dose structured report not required Technologist 3.1.3.1.3: radiopharmaceutical administration route Excludes saline flush and checking for infiltration Technologist 3.2.1.1: timing of image data acquisition Same Technologist 3.2.1.2: subject positioning Does not cover strict serial scan positioning Technologist 3.2.1.3: scanning coverage and direction Same Technologist 3.2.1.4: scanner acquisition mode parameters: PET acquisition Same except does not cover if scan is stopped and restarted Technologist 3.2.1.4: scanner acquisition mode parameters: CT acquisition Not required Technologist 3.3.1: imaging data reconstruction Same except point spread function is allowed Image Analyst 4.4: performance assessment: image analysis workstation Not required Profile stages Description Public comment Biomarker committee experts have drafted profile and believe it is practical and expect it to achieve claimed performance Consensus Wider community has read profile and judged it to be practical and expect it to achieve claimed performance Technically confirmed Several sites have performed profile and found it to be practical and expect it to achieve claimed performance (status of the profile) Claim confirmed Some sites have performed profile and found that it achieved claimed performance Clinically confirmed Many sites have performed profile and demonstrated claimed performance is widely achievable
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