Flutemetamol F18 Injection
The First-and-Only Amyloid Imaging Agent with FDA Approval for Color Image Interpretation
Flutemetamol F18 Injection color images provided accurate amyloid detection
In Study 1:
Hign median sentivity and specificity in autopsy standard-of-truth assesment among five independent, blinded image readers.
In Study 2:
• Flutemetamol F18 Injection color image reads demonstrated high inter-reader agreement for visual image interpretation (kappa score 0.83, 95% CI [0.79-086])
• An intra-reader reproducibility analysis involving two readings for each of 29 duplicate patient images showed: One of the five readers ahd complete agreement for all 29 images, two readers had discordant reads for a single image, and two readers had discordant reads for two images.
• Intra-reader reproducibility for a subgroup of eight images from aMCI patients showed: All five readers had complete agreement for all duplicate images.
*AMCI – Amnestic Mild Cognitive Impairment
- A negative Flutemetamol F18 Injection scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of Alzheimer’s disease at the point of image acquisition
- A positive Flutemetamol F18 Injection scan indicates moderate to frequent amyloid neuritic plaques
- Flutemetamol F18 Injection is an adjunct to other diagnostic evaluates
- With persistent or progressive unexplained MCI
- Who satisty core clinical criteria for possible Alzheimer’s disease because pf unclear clinical presentation, either a typical clinical course or an etiologically mixed presentation
- With progressive dementia and a typically early age of onset (usually defined as < 65)
In clinical trials of 761 patients dosed, one experienced a serious hypersensitivity reaction.
- This reaction was accompanied by flushing, dyspnea, and chest pressure
- The reaction occured within minutes of administration of Flutemetamol F18 Injection, and the patient recovered with treatment.
- The most commonly reported adverse reactions occured at a rate of <2% and were of mild to moderate intensity
- The recommended dose is 185 MBq (5 mCi) injected intravenously. The adult effective dose is 5.92 mSv
Color Image Interpretation provides an estimate of B-amyloid neuritic plaque density
- Flutemetamol F18 binds B-amyloid plaques in the brain, and the F18 isotope produces a position signal that is detected by a positron-emission tomography (PET) scanner
- Accurate amyloid detection as demonstrated by high sensitivity and specificaly in Phase 3 clinical trials
- Consistent and reliable results, with high inter-reader agreement for visual image interpretation.