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 (CArdiag)

NCT05184088 Phase 3 RECRUITING

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.

Details

Lead sponsor	Life Molecular Imaging GmbH
Phase	Phase 3
Status	RECRUITING
Enrolment	200
Start date	2023-01-13
Completion	2026-03

Conditions

• Cardiac Amyloidosis
• AL Amyloidosis
• ATTR Amyloidosis

Interventions

• [18F]florbetaben

Primary outcomes

• Sensitivity and specificity of the visual assessment of [18F]florbetaben PET images for the diagnosis of cardiac AL amyloidosis. — Up to 12 weeks
  The results from the visual assessment of \[18F\]florbetaben PET images are compared to the clinical diagnosis established through histological verification of the presence or absence of AL amyloidosis with cardiac involvement determined either through endomyocardial biopsy or through extracardiac biopsy in conjunction with typical CMR or echocardiography imaging features as the standard of truth.

Countries

United States, Germany, Spain, United Kingdom