Last reviewed · How we verify
NCT03616496: CAPRI
Assessment of 18F-Florbetaben Whole-body PET for the Detection of Cardiac and Extracardiac Sites of Amyloid Deposits
NA trial testing Neuraceq PET/CT imaging in Cardiac Amyloidosis in 67 participants. Completed in 10 February 2025.
30 January 2025
Quick facts
| Lead sponsor | Central Hospital, Nancy, France |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 67 |
| Start date | 6 June 2019 |
| Primary completion | 30 January 2025 |
| Estimated completion | 10 February 2025 |
| Sites | 1 location across France |
Drugs / interventions tested
- Neuraceq PET/CT imaging — full drug profile →
Conditions studied
- Cardiac Amyloidosis — all drugs for Cardiac Amyloidosis →
Sponsor
Central Hospital, Nancy, France
Who can join
18 and older, any sex, with Cardiac Amyloidosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03616496
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cardiac Amyloidosis
Currently open trials in the same condition.
- NCT07232459 — [18F]FT8 PET Imaging in Immunoglobulin Light Chain Amyloidosis · recruiting
- NCT06788535 — Research With I-124 EVuzamitide to Elucidate Cardiac AmyLoidosis · Phase 3 · active not recruiting
- NCT06458374 — ATTR Cardiac Amyloidosis in a Selected Population · recruiting
- NCT06427304 — Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure · recruiting
- NCT06907836 — Description of a Retrospective Cohort of Patients With Transthyretin Cardiac Amyloidosis (ATTR-CA) in Internal Medicine · recruiting
Other Central Hospital, Nancy, France trials
Trials by the same sponsor.
- NCT06452290 — PET Biomarker Study for Antidepressant Response Prediction in Major Depressive Disorder · NA · not yet recruiting
- NCT07518498 — Hypnosis During Mechanical Ventilation Weaning · NA · not yet recruiting
- NCT07471334 — Prospective Study of Postictal Psychotic Symptoms Occuring After Video-EEG Monitoring in Focal Epilepsies · NA · not yet recruiting
- NCT07414667 — Primary Sjögren's Syndrome: Impact of Quantitative Anti-Ro52 Antibody Analysis on Patient Prognosis and Stratification ( · not yet recruiting
- NCT07415759 — Imaging of Electrical Properties by MRI: Investigation of Age-Related Changes · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03616496 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Central Hospital, Nancy, France
- Last refreshed: 11 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03616496.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing