Tracer library / [18F]flutemetamol
[18F]flutemetamol
Also written as [18F]Flutemetamol; [F-18]Flutemetamol; Flutemetamol
- Radionuclide
- F-18 t½ 109.77 min
- Modality
- PET
- Production route
- —
- Stage
- Approved
- Syntheses indexed
- 1
What it is
- Compound class
- Radiolabelled benzothiazole derivative (amyloid-binding small molecule)
- Target / mechanism
- β-amyloid aggregates FDA label NDA203137
- Clinical application
- PET imaging of the brain to estimate β-amyloid neuritic plaque density in adults with cognitive impairment, for evaluation of Alzheimer's disease and other causes of cognitive decline FDA label NDA203137
- Theranostic pair
- —
Regulatory status
- FDA
- 2013, Vizamyl, GE Healthcare FDA (Drugs@FDA/openFDA): NDA203137, approved 2013-10-25
- EMA (centralised)
- 2014, Vizamyl, GE Healthcare EMA medicines register export (2026-09-09): EMEA/H/C/002557, 'Authorised'
- Other approvals
- —
- Brand names
- Vizamyl
Clinical use
- Typical injected activity
- 185 MBq (5 mCi) single IV bolus within 40 seconds, up to 10 mL FDA label NDA203137 (human clinical dosing)
- Uptake time
- Signal increases continually 0–30 min post-injection, then stable from 30 min to at least 120 min FDA label NDA203137
Reported in the literature. Not a dosing recommendation.
Published syntheses
| Module | Cassette | Purification | Yield % | RCP % | Precursor / supplier | Source |
|---|---|---|---|---|---|---|
| FASTlab GE HealthCare | — | — | — | — | — | 25366546 2015 Pharm Res The influence of polysorbate 80 on the radiochemical synthesis of a PET tracer in the FASTlab. |
Clinical literature
Clinical studies in the indexed corpus, ordered by design (multicentre, prospective, retrospective, others, case reports last) and then by year. Titles and links only, as published; this is not a summary of the evidence.
- Automatic lesion detection and segmentation in 18F-flutemetamol positron emission tomography images using deep learning.2022 · Biomed Eng Online · Clinical study
- CSF biomarkers of Alzheimer's disease concord with amyloid-β PET and predict clinical progression: A study of fully automated immunoassays in BioFINDER and ADNI cohorts.2018 · Alzheimers Dement · Clinical study
- Concordance Between Different Amyloid Immunoassays and Visual Amyloid Positron Emission Tomographic Assessment.2017 · JAMA Neurol · Clinical study
- Automated quantification of 18F-flutemetamol PET activity for categorizing scans as negative or positive for brain amyloid: concordance with visual image reads.2014 · J Nucl Med · Clinical study
- Combination of biomarkers: PET [18F]flutemetamol imaging and structural MRI in dementia and mild cognitive impairment.2012 · Neurodegener Dis · Clinical study
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Get in touchQuality control Preliminary - inferred from compound class
- Ph. Eur. monograph
- not verified No Ph. Eur. check is recorded for this entry.
- USP monograph
- not verified No USP check is recorded for this entry.
How this set was arrived at. base set per Ph. Eur. general monograph 0125 (rule); organic-phase radiosynthesis assumed from isotope/compound class, no synthesis data confirming it -> GC residual solvents (preliminary); conventional nucleophilic 18F-fluorination assumed from isotope/compound class, no synthesis data confirming K222 use -> Kryptofix test (preliminary)
Tests listed by reference only. Monograph texts are copyrighted and are not reproduced here. How these are derived
Setting up quality control?We can help you scope the equipment needed to release [18F]flutemetamol.
Get in touchNotes
Added from reverse module search (stage 6); 7 article(s) with F-18.