Assessment of 18F-Florbetaben Whole-body PET for the Detection of Cardiac and Extracardiac Sites of Amyloid Deposits
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
Although being classified as a rare disease, cardiac amyloidosis constitutes an increasing
cause of heart failure, which is often overlooked and thus poorly managed. Amyloidosis
involves deposits of light chain immunoglobulins in the immunoglobulin light chain
amyloidosis (AL) type, but it may also be of a hereditary type in mutated transthyretin
amyloidosis (ATTRm) or of a senile type in wildtype transthyretin forms (ATTRwt).
Myocardial biopsy remains a gold standard for definitive diagnosis but it is a traumatic
technique which only provides information on a limited number of sampled sites.
Useful but not fully specific signs of cardiac amyloidosis may also be provided by Magnetic
Resonance Imaging or MRI (delayed retention imaging) and echocardiography (longitudinal
strain pattern).
Notwithstanding the above, relatively specific markers of amyloid plaques are now available
in Positron Emission Tomography (PET). These markers are primarily fluorinated tracers which
have been developed for the diagnosis of Alzheimer's disease. Two of these have already been
the subject of feasibility studies in the setting of cardiac amyloidosis diagnosis, on a
maximum of 10 amyloidosis patients but with very favorable results.
The hypothesis is that one of these two tracers, Florbetaben labelled with
Fluorine-18-Florbetaben (18F-Florbetaben) used in the study, has sufficiently strong and
prolonged binding kinetics at the level of the amyloid plaques to allow: (i) achieving
whole-body PET recordings and thus, (ii) identifying not only cardiac amyloidosis but also
extracardiac binding sites, particularly those readily accessible to biopsy sampling. This
hypothesis has been strengthened by a recent case report illustrating the ability of
whole-body florbetaben-PET to image not only cardiac but also extra-cardiac sites of amyloid
deposits (Clin Nucl Med. 2017;42(1):50-3).