Avid Radiopharmaceuticals/Eli Lilly and Company
Clinical Development
Leonardo Iaccarino is currently Director in Clinical Development at Avid, Eli Lilly and Company. He has obtained a PhD at the Vita-Salute San Raffaele University (Italy) and has conducted postgraduate research studies at the University of California San Francisco (USA). His research activities have been focusing on leveraging PET molecular neuroimaging techniques in Alzheimer’s Disease and related disorders to investigate neurodegeneration, protein accumulation and neuroinflammation dynamics.

Presenter of 1 Presentation

A COMPARISON OF TWO NOVEL VISUAL READ-BASED METHODS FOR HIGH TAU IDENTIFICATION FROM FLORTAUCIPIR-PET

Session Type
SYMPOSIUM
Date
Sat, 01.04.2023
Session Time
08:40 - 10:40
Room
ONSITE - HALL G3
Lecture Time
09:55 - 10:10

Abstract

Aims

To compare the performances of two novel visual read-based methods for flortaucipir-PET in patients with Alzheimer’s Disease (AD) to identify high tau accumulation, defined as AD-signature weighted neocortical Standardized Uptake Value ratio (SUVr)>1.46.

Methods

Baseline flortaucipir-PET scans displaying advanced-AD tau-patterns (increased neocortical activity beyond posterior lateral temporal and occipital regions with bindings 1.65-times higher [1.65x-visual threshold] than cerebellar average) were utilized from the confirmatory phase of A05 study (N=78, NCT02016560). Four expert human-readers conducted reads using two novel visual read-based methods while being blinded to each other and all quantitative results. The first approach (SUVrmax-method) requires a reader to visually identify and hand-draw focal regions-of-interest on frontal areas with the highest bindings and calculate an SUVr between the identified frontal maximum and average cerebellum binding. The second approach (Enhanced Read-method) requires the reader to evaluate binding elevation compared to cerebellum with an enhanced visual threshold, either across gray matter (global, 3.795x-visual threshold) or only in the frontal lobe (2.805x-visual threshold), compared to the standard 1.65x-visual threshold specified in the FDA-approved Tauvid™ label. Methods were compared to the standard quantitative high tau determination as standard-of-truth.

Results

Based on a previously found ROC-determined cut point using computer-generated SUVrmax values, the SUVrmax-method showed median 88% Positive Percent Agreement (PPA), 87% Negative Percent Agreement (NPA) and 87% overall accuracy across raters. The Enhanced Read-method showed median 75% PPA, 88% NPA and 85% overall accuracy and median 81% PPA, 91% NPA and 88% overall accuracy for global and frontal approaches, respectively.

Conclusions

Both novel flortaucipir-PET visual read-based methods showed comparable and promising performances in identifying AD with high tau, do not require computationally intensive approaches and can be implemented with different imaging software.

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