Flutemetamol F-18

Flutemetamol F-18 (Vizamyl, GE HealthCare) was FDA-approved in October 2013 for PET imaging of the brain to estimate beta-amyloid neuritic plaque density in adults with cognitive impairment being evaluated for AD and other causes of cognitive decline. As with the other amyloid tracers, the US label was updated (current version dated 2025/2026) to add a second indication, selection of patients indicated for amyloid beta-directed therapy, alongside the diagnostic indication. The EMA-approved indication (EPAR, EU) is imaging to help diagnose Alzheimer's disease and other causes of memory loss.

The recommended dose is 185 MBq (5 mCi) given as an intravenous bolus over 40 seconds in up to 10 mL, maximum mass dose 20 micrograms, with 10 to 20-minute PET images acquired 60 to 120 minutes after injection; the resulting effective dose is about 5.9 mSv (32 microSv/MBq). Vizamyl is contraindicated in patients with known hypersensitivity to polysorbate 80, an excipient, which is a distinguishing safety point versus the other amyloid tracers.

Interpretation is by visual assessment of grey-white matter contrast (a positive scan shows loss of the normal grey-white distinction from cortical tracer retention), and flutemetamol has a validated tracer-specific linear conversion to the Centiloid scale, allowing quantitative reporting alongside the qualitative read. In the US, amyloid PET coverage for Medicare beneficiaries, including flutemetamol scans, follows the post-2023 framework in which CMS retired the national coverage determination and left individual coverage decisions to local Medicare Administrative Contractors, removing the former one-scan-per-lifetime limit.