Objective:

The objectives of this work include 1) Evaluating the efficacy of the approved visual assessment (VA) method in the routine clinical practice and 2) Presenting results of 15 quantitative pipelines to underscore reliability and added value of quantification. 

Background:

Positron emission tomography (PET) scanning with florbetaben (FBB) was approved in the US in 2014 after validation in histopathological studies for imaging of amyloid plaques in individuals being evaluated for Alzheimer's disease (AD). This abstract incorporates real-world evidence of FBB’s clinical and research use, including results from visual and quantitative assessment of amyloid PET images. 

Design/Methods:

The effectiveness of FBB VA has been evaluated in real world settings in the PASS 1 study (EUPAS12145). Fifty nuclear medicine physicians of various levels of VA experience assessed 20 FBB PET scans at baseline and re-assessed the same scans 6 months later. Their performance was compared to that of 15 quantitative pipelines analyzing the same 20 FBB scans.  

Results:

The studies’ results confirmed that both experts and naïve readers accurately assess FBB PET scans and maintain these abilities over time (correct assessments: 96% at baseline and 92% at 6 months follow-up). Quantitative methods, including 510(k) approved software, consistently demonstrated robust and homogeneous performance (accuracy 96.4±1.1%), offering valuable support for visual assessments. 

Conclusions:

Since its approval, VA and quantification of FBB images have undergone additional validation across diverse settings including clinical routine. FBB PET imaging is a validated, reliable, and available tool in the diagnostic pathway of AD, as indicated within the Alzheimer’s Association’s (AA) Updated Criteria for AD Diagnosis and Staging and the AA/Society for Nuclear Medicine’s Appropriate Use Criteria for PET. With the approval of amyloid-targeting therapies and recent FBB labeling expansions to include quantification and patient selection, standardized quantification approaches, such as the Centiloid scale, are becoming increasingly important.