Clinical Usefulness of ¹â¸F-FC119S Positron-Emission Tomography as an Auxiliary Diagnostic Method for Dementia: An Open-Label, Single-Dose, Evaluator-Blind Clinical Trial
10.3988/jcn.2020.16.1.131
- Author:
Inki LEE
1
;
Hae Ri NA
;
Byung Hyun BYUN
;
Ilhan LIM
;
Byung Il KIM
;
Chang Woon CHOI
;
In Ok KO
;
Kyo Chul LEE
;
Kyeong Min KIM
;
Su Yeon PARK
;
Yu Keong KIM
;
Jun Young LEE
;
Seon Hee BU
;
Jung Hwa KIM
;
Hee Seup KIL
;
Chansoo PARK
;
Dae Yoon CHI
;
Jeong Ho HA
;
Sang Moo LIM
Author Information
1. Department of Nuclear Medicine, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, Korea. smlim328@kirams.re.kr
- Publication Type:Original Article
- From:Journal of Clinical Neurology
2020;16(1):131-139
- CountryRepublic of Korea
- Language:English
-
Abstract:
BACKGROUND:AND PURPOSE: The aim of this study was to determine the diagnostic performance and safety of a new ¹â¸F-labeled amyloid tracer, ¹â¸F-FC119S.
METHODS:This study prospectively recruited 105 participants, comprising 53 with Alzheimer's disease (AD) patients, 16 patients with dementia other than AD (non-AD), and 36 healthy controls (HCs). In the first screening visit, the Seoul Neuropsychological Screening Battery cognitive function test was given to the dementia group, while HC subjects completed the Korean version of the Mini Mental State Examination. Individuals underwent ¹â¸F-FC119S PET, ¹â¸F-fluorodeoxyglucose (FDG) PET, and brain MRI. The diagnostic performance of ¹â¸F-FC119S PET for AD was compared to a historical control (comprising previously reported and currently used amyloid-beta PET agents), ¹â¸F-FDG PET, and MRI. The standardized uptake value (SUV) ratio (ratio of the cerebral cortical SUV to the cerebellar SUV) was measured for each PET data set to provide semiquantitative analysis. All adverse effects during the clinical trial periods were monitored.
RESULTS:Visual assessments of the ¹â¸F-FC119S PET data revealed a sensitivity of 92% and a specificity of 84% in detecting AD. ¹â¸F-FC119S PET demonstrated equivalent or better diagnostic performance for AD detection than the historical control, ¹â¸F-FDG PET (sensitivity of 80.0% and specificity of 76.0%), and MRI (sensitivity of 98.0% and specificity of 50.0%). The SUV ratios differed significantly between AD patients and the other groups, at 1.44±0.17 (mean±SD) for AD, 1.24±0.09 for non-AD, and 1.21±0.08 for HC. No clinically significant adverse effects occurred during the trial periods.
CONCLUSIONS:¹â¸F-FC119S PET provides high sensitivity and specificity in detecting AD and therefore may be considered a useful diagnostic tool for AD.
