A prospective single-arm, monocentric study on the possibility to use the PET tracer (18F)-florbetaben (Neuraceq®) in patient with patient with suspected cardiac amyloidosis in order to make diagnosis.

Phase 1

• Conditions: Patients with high clinical suspicion of cardiac amyloidosis; MedDRA version: 20.0Level: PTClassification code 10007509Term: Cardiac amyloidosisSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-005384-16-IT
• Lead Sponsor: FONDAZIONE TOSCANA GABRIELE MONASTERIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-24
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Age>20 years, high clinical suspicion of cardiac amyloidosis based on cardiac examination, biomarkers (Nt-proBNP, HS-TnT, immunoglobulin light chains in serum and urine, plasma protein electrophoresis and serum free light chains), baseline ECG, baseline echocardiography, cardiac MRI, histological evidence of amyloid in periumbelical fat (Congo red stain).
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

Pregnancy checked by plasma beta-HCG or breast feeding, known ischemic heart disease, hypertrophic cardiomyopathy, storage diseases or other known causes of left ventricule hypertrophy or pseudohypertrophy, hypersensitivity to the active substance or to any of the excipients of the study drug Neuraceq®, renal failure, liver failure.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Establish the affinity of the tracer [18F] -Florbetaben for amyloid deposits in patients with clinican suspition of cardiac amyloidosis AL and ATTR.;Secondary Objective: - Check the possible correlation between the extent of the tracer uptake and the signs of cardiac involvement assessed on MRI.<br>- Evaluate if the PET tracer [18F] -Florbetaben for brain amyloid could also show an uptake in extracranial and extracardiac amyloid depositions.;Primary end point(s): Qualitatively and quantitatively evaluation of the extent of tracer myocardial uptake in patients with cardiac amyloidosis both AL and ATTR.;Timepoint(s) of evaluation of this end point: 150 minutes (no follow-up visits are needed; the endpoint evaluation is concomitant with the PET examination).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To establish the correlation between regional uptake of the radiopharmaceutical and regional patterns of LGE derived from MRI and quantify any other tissue uptake of the radiopharmaceutical compatible with the presence of amyloid deposits (systemic amyloidosis).;Timepoint(s) of evaluation of this end point: 150 minutes (no follow-up visits are needed; the endpoint evaluation is concomitant with the PET examination).