cardiac amyloidosis MedDRA version: 20.0 Level: PT Classification code 10007509 Term: Cardiac amyloidosis System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: PT Classification code 10007509 Term: Cardiac amyloidosis System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: NEURACEQ - 300 MBQ/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO (VETRO) - 1 FLACONCINO MONODOSE
Product Name: Neuraceq 300MBq/mL soluzione iniettabile
Product Code: Neuraceq 30
Sponsors
FONDAZIONE TOSCANA GABRIELE MONASTERIO
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the specificity of the tracer [18F]-Florbetaben for amyloid deposits in patients with cardiac amyloidosis AL and ATTR by comparison with a control group represented by patients with left-ventricular non-infiltrative hypertrophic cardiomyopathy.;Secondary Objective: 1. Set modality and timing of PET/CT scans in order to obtain a differential diagnosis between the two types of cardiac amyloidosis by comparison with a control group represented by patients with left-ventricular non-infiltrative hypertrophic cardiomyopathy; 2. Identify possible differences in regional distribution of the tracer between the two groups of patients with cardiac amyloidosis and in patients with left-ventricular non-infiltrative hypertrophic cardiomyopathy.;Primary end point(s): Qualitatively and quantitatively evaluation of myocardial uptake in patients with cardiac amyloidosis both AL and ATTR and in patients with non-infiltrative hypertrophic cardiomyopathy.;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Find the best timing for the acquisition of PET/CT scans able to differentiate between AL and ATTR by comparison with a control group consisting of patients with left-ventricular non-infiltrative hypertrophic cardiomyopathy; 2. Give information on regional ventricular uptake of the radiotracer in relation to the type of amyloidosis by comparison with a control group consisting of patients with left-ventricular non-infiltrative hypertrophic cardiomyopathy.;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) | — |
Countries
Italy
Contacts
Public ContactU.O.C. Farmaceutica Ospedaliera
Fondazione Toscana Gabriele Monasterio
Outcome results
None listed