J Clin Neurol.  2020 Jan;16(1):131-139. 10.3988/jcn.2020.16.1.131.

Clinical Usefulness of ¹⁸F-FC119S Positron-Emission Tomography as an Auxiliary Diagnostic Method for Dementia: An Open-Label, Single-Dose, Evaluator-Blind Clinical Trial

• Lee I
• Na HR
• Byun BH
• Lim I
• Kim BI
• Choi CW
• Ko IO
• Lee KC
• Kim KM
• Park SY
• Kim YK
• Lee JY
• Bu SH
• Kim JH
• Kil HS
• Park C
• Chi DY
• Ha JH
• Lim SM

• KMID: 2467795
• DOI: http://doi.org/10.3988/jcn.2020.16.1.131

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.

Keyword

¹⁸F-FC119S; Alzheimer's disease; dementia; amyloid beta-peptides; positron-emission tomography; clinical trial

MeSH Terms

Alzheimer Disease
Amyloid
Amyloid beta-Peptides
Brain
Cognition
Dataset
Dementia*
Humans
Magnetic Resonance Imaging
Mass Screening
Methods*
Positron-Emission Tomography*
Prospective Studies
Sensitivity and Specificity
Seoul
Amyloid
Amyloid beta-Peptides

Figure

• 

  Fig. 1 Transaxial (upper and middle rows) and sagittal (lower row) 18F-FC119S PET images. A: A 77-year-old male patient clinically diagnosed with Alzheimer's disease (K-MMSE score=16) showed highly increased uptakes in the gray matter and no sulcal pattern. B: A 74-year-old female patient clinically diagnosed with vascular dementia (K-MMSE score=20) showed similar 18F-FC119S uptakes in the white and gray matter. C: A 73-year-old female healthy control (K-MMSE score=30) showed low 18F-FC119S uptakes throughout the brain and similar uptakes in the white and gray matter. K-MMSE: Korean version of the Mini Mental State Examination, SUV: standardized uptake value.

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