A prospective study on evaluation of diagnostic efficacy of the PET tracer (18F)-florbetaben (Neuraceq®) in patients with cardiac amyloidosis - FLORAMICAR 2

Phase 1

• Conditions: 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: EUCTR2017-001660-38-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: 21 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Group of patients with cardiac amyloidosis AL and ATTR: males or females, age>20 years, patient with diagnosis of cardiac amyloidosis.
Group of patients with non-infiltrative hypertrophic cardiomyopathy: males or females, age>20 years, non-infiltrative hypertrophic cardiomyopathy.
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Patients previously enrolled in FLORAMICAR study (EudraCT 2015-005384-16), pregnancy checked by plasma beta-HCG or breastfeeding, known ischemic heart disease, hypertrophic cardiomyopathy, storage diseases or other known causes of left ventricular hypertrophy or pseudohypertrophy, hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the Summary of Product Characteristics (SPC) Neuraceq®, severe renal failure, liver failure, PET / CT or scintigraphic examination 24 h before enrollment.

Study & Design

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