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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 will be determined by comparison to the standard of truth (SoT) obtained through standard of care clinical diagnosis based on endomyocardial biopsy or extracardiac biopsy together with typical cardiac magnetic resonance (CMR) or echocardiography imaging features. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05184088
Study type Interventional
Source Life Molecular Imaging SA
Contact Iris Hardewig, PhD
Phone +49 (0)30 461 1246 03
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date April 2022
Completion date September 2024

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