Performance Characteristics of Amyloid PET with Florbetapir F 18 in Patients with Alzheimer's Disease and Cognitively Normal Subjects

Journal of Nuclear Medicine

Daniel M. Skovronsky¹  Mark A. Mintun¹  Abhinay D. Joshi¹  Jason D. Burns¹  John P. Seibyl¹  Alan P. Carpenter¹  Karel D. Kovnat¹  Anupa Arora¹  Carl H. Sadowsky¹  Lee P. Adler¹  Chrisopher M. Clark¹  Danna L. Jennings¹  Michael J. Pontecorvo¹  Krishnendu Saha¹  the Florbetapir F 18 Study Investigators¹  Mark J. Lowrey¹ 

关键词: Aβ;    florbetapir;    PET;    biomarkers;    test–retest;    dose ranging;   

DOI  :  10.2967/jnumed.111.090340

学科分类：医学（综合）

来源: Society of Nuclear Medicine

【 摘 要 】

The objectives of this study were to examine the effective dose range and the test–retest reliability of florbetapir F 18 using, first, visual assessment by independent raters masked to clinical information and, second, semiautomated quantitative measures of cortical target area to cerebellum standardized uptake value ratios (SUVr) as primary outcome measures. Visual ratings of PET image quality and tracer retention or β-amyloid (Aβ) binding expressed as SUVrs were compared after intravenous administration of either 111 MBq (3 mCi) or 370 MBq (10 mCi) of florbetapir F 18 in patients with Alzheimer's disease (AD) (n = 9) and younger healthy controls (YHCs) (n = 11). In a separate set of subjects (AD, n = 10; YHCs, n = 10), test–retest reliability was evaluated by comparing intrasubject visual read ratings and SUVrs for 2 PET images acquired within 4 wk of each other. Results: There were no meaningful differences between the 111-MBq (3-mCi) and 370-MBq (10-mCi) dose in the visual rating or SUVr. The difference in the visual quality across 111 and 370 MBq showed a trend toward lower image quality, but no statistical significance was achieved (t test; t1 = −1.617, P = 0.12) in this relatively small sample of subjects. At both dose levels, visual ratings of amyloid burden identified 100% of AD subjects as Aβ-positive and 100% of YHCs as Aβ-negative. Mean intrasubject test–retest variability for cortical average SUVrs with the cerebellum as a reference over the 50- to 70-min period was 2.4% ± 1.41% for AD subjects and 1.5% ± 0.84% for controls. The overall SUVr test–retest correlation coefficient was 0.99. The overall κ-statistic for test–retest agreement for Aβ classification of the masked reads was 0.89 (95% confidence interval, 0.69–1.0). Conclusion: Florbetapir F 18 appears to have a wide effective dose range and a high test–retest reliability for both quantitative (SUVr) values and visual assessment of the ligand. These imaging performance properties provide important technical information on the use of florbetapir F 18 and PET to detect cerebral amyloid aggregates.

【 授权许可】

Unknown