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

AL 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

Status Recruiting

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. ;

Related Conditions & MeSH terms

• AL Amyloidosis
• Amyloidosis
• ATTR Amyloidosis
• Cardiac Amyloidosis
• Immunoglobulin Light-chain Amyloidosis

• 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