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

Cardiac Amyloidosis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05184088
Study type Interventional
Source Life Molecular Imaging SA
Contact Iris Hardewig, PhD
Phone +49 (0)30 461 1246 03
Email clinicaltrials@life-mi.com
Status Recruiting
Phase Phase 3
Start date January 13, 2023
Completion date June 2025
View Details
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