Skip to content
Open access

18F-flortaucipir PET imaging: Biodistribution in the Japanese population and diagnostic accuracy by Japanese readers.

Jul 2026 · Annals of Nuclear Medicine · 0 citations · 17 references
Medicine

TL;DR

The biodistribution of 18F-flortaucipir whole-body biodistribution for Japanese individuals was consistent with that of non-Japanese individuals, and Japanese readers showed high concordance with US readers on the interpretation of 18F-flortaucipir PET images to distinguish between AD and non-AD patterns.

Abstract

Objective

18F-flortaucipir (Tauvid™) is an 18F-labeled diagnostic positron emission tomography (PET) radiopharmaceutical, which was developed to detect tau pathology in the brain and to estimate the density and/or distribution of aggregated tau neurofibrillary tangles for patients being evaluated for Alzheimer's disease (AD). The objective of this article is to report findings from two studies. The primary objective of the first (dose and biodistribution) study was to investigate the consistency of 18F-flortaucipir PET biodistribution between Japanese and non-Japanese individuals. In the second (reader) study, the comparability of visual reads performed by Japanese and US expert readers who followed the same training program was evaluated.

Methods

This article reports findings from two separate studies and datasets. In the dose and biodistribution study, whole-body distribution of 18F-flortaucipir was assessed (N = 9). Standardized uptake value ratios, normalized to the entire cerebellum, were calculated, and whole-body effective dose was calculated using a 73.7 kg bodyweight model. In the reader study (Study A27; I7E-AV-A27), five Japanese physicians visually interpreted 60 PET scans randomly selected from a previous US reader study (Study FR01; NCT03901092). Scan positivity was determined based on increased activity of 18F-flortaucipir in posterolateral temporal, occipital, or parietal/precuneus regions with or without frontal activity. Each scan was visually interpreted by all Japanese readers, who determined whether scans were consistent with an AD or non-AD pattern. Concordance between Japanese and US readers who underwent the same training on the interpretation of 18F-flortaucipir PET images was then evaluated (reader study primary endpoint).

Results

The biodistribution of 18F-flortaucipir was consistent between Japanese and non-Japanese individuals. When interpreting 18F-flortaucipir PET images to distinguish between AD versus non-AD patterns, Japanese and US readers who underwent the same training showed 100% agreement on the majority reads, with a Cohen's Kappa value of 1.

Conclusions

18F-flortaucipir whole-body biodistribution for Japanese individuals was consistent with that of non-Japanese individuals. After completing the same training, Japanese readers showed high concordance with US readers on the interpretation of 18F-flortaucipir PET images to distinguish between AD and non-AD patterns. Data and scans were from previous studies registered with ClinicalTrials.gov (registration numbers: NCT04474405; NCT03901092).

Read PDF

Similar papers

Aug 2026

Regional differences in 18F-flutemetamol accumulation between amyloid-positive and -negative brains using high-resolution dedicated head PET scanner.

High-resolution dhPET revealed significantly higher SUVRs in Aβ⁺ compared with Aβ⁻ subjects in supratentorial structures, including cerebral white matter, and in cerebellar gray matter.

Yasuyuki Kojita, Kazunari Ishii, Takahiro Yamada et al. · 0 citations
Review Jul 2026

[18F]-florzolotau PET imaging in Alzheimer's disease: Current evidence and future directions

Tau positron emission tomography (PET) has become a central imaging modality for in vivo detection and quantification of tau pathology across the Alzheimer's disease (AD) clinical and biological continuum. [18F]-Florzolotau is a second-generation tau PET tracer developed to improve target-to-background contrast and mitigate off-target binding relative to first-generation ligands, thereby improving interpretability for translational research and clinical use. In this narrative review, we provide a critical appraisal of the available literature on [18F]-Florzolotau PET imaging in AD, with emphasis on diagnostic and differential-diagnostic performance, the spatiotemporal topography of tau deposition in relation to Braak staging and disease progression, and the clinical significance of tracer uptake with respect to cognitive measures, disease severity, and prognosis. Eligible studies were clinical investigations published between 2020 and 2025 that applied [18F]-Florzolotau PET in cohorts spanning cognitively unimpaired individuals through symptomatic AD stages. Across reports, [18F]-Florzolotau PET differentiated AD dementia from cognitively unimpaired comparators with high accuracy, with sensitivities ≥ 90% and specificities of 87–96%. Regional uptake patterns were broadly consistent with Braak-like propagation, progressing from medial temporal regions toward associative neocortex in parallel with increasing clinical severity. Quantitative tracer uptake also correlated with global cognition and key domains, including episodic memory and executive function. We conclude that [18F]-Florzolotau PET provides a robust in vivo measure of AD tau burden, motivating further evaluation for diagnostic and prognostic applications. Larger multicenter studies with harmonized acquisition/quantification and head-to-head comparisons versus other second-generation tracers remain priorities.

Simone Lista, P. Minoretti, Enzo Emanuele et al. · 0 citations
Open access Aug 2026

Concordance Between [18F]Flortaucipir PET Visual Reads and CenTauR-Based Quantification.

Tau PET imaging with [18F]flortaucipir allows for the visualization and mapping of aggregated tau deposits, a key neuropathologic feature of Alzheimer disease (AD). A visual interpretation method for [18F]flortaucipir was approved by the Food and Drug Administration and European Medicines Agency and has been implemented for a standardized, clinically usable definition of tau PET positivity. The CenTauRz method, on the other hand, offers the possibility to harmonize the definition of tau PET positivity across different radiotracers using quantitative metrics, but its concordance with clinically relevant [18F]flortaucipir visual reads remains unclear. Methods: A convenience sample of 3991 participants, including cognitively unimpaired (CU) and cognitively impaired (CI) individuals (i.e., those with mild cognitive impairment or AD dementia), underwent [18F]flortaucipir PET imaging. Each [18F]flortaucipir scan was assessed by 3 trained readers using the approved visual interpretation method and quantified using the CenTauRz quantification pipeline in different regions of interest (ROIs). Concordance between positive visual reads and CenTauRz-defined positivity (i.e., >2 on the CenTauRz scale) was assessed using Cohen κ. Receiver-operating-characteristic (ROC) analysis evaluated the discriminative power of continuous CenTauRz values in distinguishing between negative and positive visual reads. Generalized additive models examined clinical progression on the basis of visual and CenTauRz-based assessments of tau PET positivity. Results: Concordance between visual reads and CenTauRz-based assessments of tau PET positivity was moderate, particularly in CU individuals (κ = 0.23-0.55 for CU participants, κ = 0.57-0.82 for CI participants, depending on the ROI). ROC analysis revealed that the agreement remained moderate, independent of the CenTauRz cut point used (area under the ROC curve, 0.72-0.87 vs. 0.87-0.97 for CU and CI individuals, respectively). Among discordant cases, participants with visually positive/CenTauRz-negative tau PET scans were more frequently amyloid-positive and exhibited faster clinical progression compared with visually negative/CenTauRz-positive individuals. Conclusion: Our findings highlight the relatively limited agreement between the visual assessment of [18F]flortaucipir PET images and CenTauRz-based quantification, particularly in CU individuals. Participants with visually positive/CenTauRz-negative tau PET scans showed a high frequency of amyloid positivity and faster clinical progression, suggesting that visual reads are more sensitive to heterogeneous, clinically relevant tau accumulation patterns not captured by ROI-based methods. These findings underscore the need for new quantification approaches to better capture the complex patterns of tau deposition, important for early AD detection and monitoring.

Stamatia Karagianni, Alexis Moscoso, Sheelakumari Raghavan et al. · 0 citations

We use cookies to run the site and, with your consent, for analytics and to show ads. See our Cookie Policy.