CAPRI (Phase III)

Investigator physician: Pr Pierre-Yves MARIE

Assessment of the ¹⁸F-florbetaben whole-body PET imaging diagnostic performance for the detection of cardiac and extracardiac sites of amyloid deposits in patients with amyloidosis

Amyloidosis

National multicenter non-randomized study with cardiac amyloidosis patients and matched controls.
Patients with AL amyloidosis, ATTR amyloidosis and matched controls will undergo the same one-day study regimen, namely:
- 1 bone scan (unless this examination has already been obtained and performed within the three months prior to inclusion, and the images are accessible in digital format and of sufficient quality).
- 1 ¹⁸F-Florbetaben Positron Emission Tomography (NeuraCeq®) scan, combined with a PET/CT scan.

NeuraCeq® 300 MBq/ml injectable solution (¹⁸F-Florbetaben) is an amyloid plaque radiopharmaceutical marketed by CURIUM Laboratories. It has obtained marketing authorization (AMM) for the diagnosis of Alzheimer's disease in France, and has been the subject of numerous validation studies in this indication.

Non-invasive confirmation or invalidation of the diagnosis of cardiac amyloidosis would represent a major advance for these patients, whose diagnosis is usually made too late, i.e. at a stage of advanced heart failure.
Whole-body ¹⁸F-Florbetaben PET/CT could also be useful for non-invasive monitoring of the overall body burden of amyloid deposits under specific treatmens (chemotherapies for AL forms, and specific treatments currently being tested for ATTR forms). Such monitoring is still impossible today.

The treatment under study: Diagnostic PET/CT au ¹⁸F-Florebetaben
Study status: Recruiting
Clinical Trial number: NCT03616496
Funding: PHRC Nationale French Ministry of Health