NCT05184088

Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis

An Open-label, Multi-center, Non-randomized Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of [18F]Florbetaben Positron Emission Tomography (PET) Imaging to Diagnose Cardiac AL Amyloidosis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Life Molecular Imaging GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq \[18F\]florbetaben and PET scanning of patients with suspected cardiac amyloidosis.

Detailed description

This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq \[18F\]florbetaben and PET scanning of patients with suspected cardiac amyloidosis or with a putative diagnosis of cardiac amyloidosis but with remaining diagnostic uncertainty (e.g., unclear etiology or cardiac manifestation) or patients with diagnosis of amyloidosis but unclear cardiac involvement. The diagnostic efficacy of the visual and quantitative assessments of \[18F\]florbetaben PET images for diagnosis of cardiac AL Amyloidosis will be determined by comparison to the standard of truth (SoT) obtained through standard of care clinical diagnosis.

Conditions

• Cardiac Amyloidosis
• AL Amyloidosis
• ATTR Amyloidosis

Interventions

Type	Name	Description
DRUG	[18F]florbetaben	All enrolled patients will undergo \[18F\]florbetaben PET imaging.

Timeline

• Start date: 2023-01-13
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2022-01-11
• Last updated: 2025-11-25

Locations

14 sites across 4 countries: United States, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated drug study