RECRUITINGINTERVENTIONAL

Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis

Molecular, Magnetic Resonance, and Echocardiographic Imaging Combined With Biomarkers of Cardiac and Clonal Disease to Predict Survival and Assess Response to Therapy in Cardiac AL Amyloidosis

About This Trial

This will be a systematic, combined, prospective assessment of the novel echographic, CMR, and PET imaging tools in newly-diagnosed patients with cardiac AL amyloidosis at baseline and after treatment.

Who May Be Eligible (Plain English)

Who May Qualify: - age more than 18; - histological diagnosis of AL amyloidosis; - measurable cardiac involvement as per current response criteria (i.e. NT-proBNP \>650 ng/L); - measurable hematologic disease (dFLC \>20 mg/L); - adequate renal function (eGFR \>30 mL/min) in order to be safely administered gadolinium; - absence of atrial fibrillation with uncontrolled heart rate; - absence of implantable cardiac devices; - absence of pulmonary amyloidosis histologically documented; - plan to start anti-plasma cell chemotherapy; - plan to assess response at the Pavia center after 6 months; - have given written willing to sign a consent form to participate. Who Should NOT Join This Trial: - non-AL amyloidosis; - NYHA class IV; - PS-ECOG \>3; - severe allergy to paramagnetic tracer; - severe claustrophobia; - pregnant or nursing women; Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * age more than 18; * histological diagnosis of AL amyloidosis; * measurable cardiac involvement as per current response criteria (i.e. NT-proBNP \>650 ng/L); * measurable hematologic disease (dFLC \>20 mg/L); * adequate renal function (eGFR \>30 mL/min) in order to be safely administered gadolinium; * absence of atrial fibrillation with uncontrolled heart rate; * absence of implantable cardiac devices; * absence of pulmonary amyloidosis histologically documented; * plan to start anti-plasma cell chemotherapy; * plan to assess response at the Pavia center after 6 months; * have given written informed consent to participate. Exclusion Criteria: * non-AL amyloidosis; * NYHA class IV; * PS-ECOG \>3; * severe allergy to paramagnetic tracer; * severe claustrophobia; * pregnant or nursing women;

Treatments Being Tested

DRUG

[18F]Florbetaben

Patients will undergo on the same day: * 18F-florbetaben PET-CT scans. The dose to be injected intravenously (6 second/mL) will be 370 MBq (for a 70 Kg patient); * standard assessment of clonal and organ disease; * echocardiography; * cardiac magnetic resonance. All the patients will undergo those evaluations at baseline and 6 months after treatment initiation.

Locations (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy