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Development and Validation of a 18F-Flortaucipir PET Visual Stratification Method.

Ilke Tunali1, Jian Wang1, Anupa K Arora1

  • 1Eli Lilly and Company, Indianapolis, Indiana; and.

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|March 13, 2025
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Summary

A new visual read method for 18F-flortaucipir PET (FTP) scans simplifies Alzheimer disease (AD) tau burden assessment. This reliable visual stratification method shows high agreement, aiding AD staging and prognosis without complex quantitation.

Keywords:
Alzheimer diseaseflortaucipir PEThigh tauvisual read method

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Area of Science:

  • Neurology
  • Radiology
  • Medical Imaging

Background:

  • Tau PET quantitation methods are crucial for Alzheimer disease (AD) research but require specialized expertise and software.
  • Current methods for measuring tau burden are complex, limiting accessibility in clinical settings.
  • There is a need for simplified, reliable methods for assessing tau pathology in AD.

Purpose of the Study:

  • To develop and validate a novel visual read method for 18F-flortaucipir PET (FTP) scans to stratify patients with AD based on tau levels.
  • To assess the feasibility and reliability of visual stratification compared to quantitative methods.
  • To evaluate the inter- and intrareader agreement of the visual read method.

Main Methods:

  • A total of 140 FTP scans from the TRAILBLAZER-ALZ 2 trial were randomly selected.
  • Five imaging physicians were trained in a visual stratification method using predefined thresholds and regions of interest.
  • Positive and negative percent agreement (PPA, NPA) with a quantitative standard of truth were calculated, along with Fleiss and Cohen kappa statistics for reliability.

Main Results:

  • The visual stratification method achieved median PPA of 83.4% and NPA of 88.9%, meeting predefined success criteria.
  • Interreader reliability (Fleiss κ) was 0.8882 and intrareader reliability (Cohen κ) was 0.9599, indicating almost perfect agreement.
  • The study successfully validated the feasibility and reliability of the FTP visual stratification method.

Conclusions:

  • The novel 18F-flortaucipir PET visual read method is a feasible and reliable tool for stratifying Alzheimer disease patients by tau burden.
  • This method simplifies tau assessment, potentially aiding in AD staging and prognosis without the need for complex quantitation.
  • Future research should expand validation with diverse populations and explore its utility in disease-modifying therapy trials.