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18 F‐flutemetamol amyloid imaging in Alzheimer disease and mild cognitive impairment: A phase 2 trial

2010; Wiley; Volume: 68; Issue: 3 Linguagem: Inglês

10.1002/ana.22068

1531-8249

Rik Vandenberghe, Koen Van Laere, Adrian Ivanoiu, Éric Salmon, Christine Bastin, Eric Triau, Steen Gregers Hasselbalch, Ian Law, Allan W. Andersen, Alex Kørner, Lennart Minthon, Gaëtan Garraux, Natalie Nelissen, Guy Bormans, Christopher Buckley, Rikard Owenius, Lennart Thurfjell, Gill Farrar, David J. Brooks,

Medical Imaging Techniques and Applications

Abstract Objective The most widely studied positron emission tomography ligand for in vivo β‐amyloid imaging is 11 C‐Pittsburgh compound B ( 11 C‐PIB). Its availability, however, is limited by the need for an on‐site cyclotron. Validation of the 18 F‐labeled PIB derivative 18 F‐flutemetamol could significantly enhance access to this novel technology. Methods Twenty‐seven patients with early‐stage clinically probable Alzheimer disease (AD), 20 with amnestic mild cognitive impairment (MCI), and 15 cognitively intact healthy volunteers (HVs) above and 10 HVs below 55 years of age participated. The primary endpoint was the efficacy of blinded visual assessments of 18 F‐flutemetamol scans in assigning subjects to a raised versus normal uptake category, with clinical diagnosis as the standard of truth (SOT). As secondary objectives, we determined the correlation between the regional standardized uptake value ratios (SUVRs) for 18 F‐flutemetamol and its parent molecule 11 C‐PIB in 20 of the AD subjects and 20 of the MCI patients. We also determined test‐retest variability of 18 F‐flutemetamol SUVRs in 5 of the AD subjects. Results Blinded visual assessments of 18 F‐flutemetamol scans assigned 25 of 27 scans from AD subjects and 1 of 15 scans from the elderly HVs to the raised category, corresponding to a sensitivity of 93.1% and a specificity of 93.3% against the SOT. Correlation coefficients between cortical 18 F‐flutemetamol SUVRs and 11 C‐PIB SUVRs ranged from 0.89 to 0.92. Test‐retest variabilities of regional SUVRs were 1 to 4%. Interpretation 18 F‐Flutemetamol performs similarly to the 11 C‐PIB parent molecule within the same subjects and provides high test‐retest replicability and potentially much wider accessibility for clinical and research use. ANN NEUROL 2010