Phase 2 FAPI-46 PET for ATTR-CM Staging and Progression
Summary
This Phase 2 exploratory clinical trial (NCT07549841) registered by the NIH through ClinicalTrials.gov will evaluate [68Ga]Ga-FAPI-46 PET imaging as a tool for staging transthyretin cardiac amyloidosis (ATTR-CM) and distinguishing patients whose disease is progressing under therapy. The study hypothesises that [68Ga]Ga-FAPI uptake reflects fibrotic activity correlating with disease severity. If validated, the tracer could serve as a novel biomarker enabling improved staging and personalised treatment strategies in ATTR-CM, an infiltrative cardiomyopathy that often goes unrecognized despite available targeted therapies.
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What changed
This ClinicalTrials.gov registration documents a newly enrolled Phase 2 exploratory study sponsored by the NIH, evaluating the use of gallium-68 labelled fibroblast activation protein inhibitor (FAPI-46) as a PET tracer for ATTR-CM staging. The trial will assess whether FAPI uptake correlates with myocardial fibrotic activity and can distinguish patients with progressive disease from those responding to transthyretin stabilisation or gene-silencing therapies.
Healthcare providers and researchers in amyloidosis care should note this study as a potential pathway to a non-invasive biomarker for ATTR-CM staging. Clinical investigators in nuclear medicine or cardiology may consider FAPI-PET as an emerging imaging modality worth monitoring as evidence accumulates. The trial does not impose compliance obligations on external parties at this stage.
Archived snapshot
Apr 25, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Exploratory Study Evaluating the Relevance of [68Ga]Ga-FAPI-46 for Staging and Identifying Progressing Patients With Transthyretin Cardiac Amyloidosis
Phase 2 NCT07549841 Kind: PHASE2 Apr 24, 2026
Abstract
Transthyretin cardiac amyloidosis (ATTR-CM) is an infiltrative cardiomyopathy caused by amyloid fibril deposition, leading to heart failure and arrhythmias. Despite advances in diagnosis, the disease remains commonly unrecognized and presents heterogeneously. Recent therapies targeting transthyretin stabilization and gene silencing have improved outcomes, but current staging systems based on biological and functional markers have limited ability to guide treatment.
Imaging techniques such as cardiac magnetic resonance (CMR) provide tissue characterization, but noninvasive molecular imaging of myocardial fibrotic activity remains limited. Positron emission tomography (PET) tracers targeting fibroblast activation protein (FAPI), labeled with gallium-68 (68Ga), offer a promising approach to detect and quantify fibroblast activity associated with myocardial remodeling.
This study aims to evaluate [68Ga]Ga-FAPI PET imaging for staging ATTR-CM and distinguishing patients with disease progression under therapy. The investigators hypothesize that [68Ga]Ga-FAPI uptake reflects fibrotic activity correlating with disease severity and progression. If validated, [68Ga]Ga-FAPI PET could serve as a novel biomarker for improved staging and personalized strategies in ATTR-CM.
Conditions: Transthyretin Cardiac Amyloidosis
Interventions: [68Ga]Ga-FAPI-46
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