RecruitingNot ApplicableNCT04392960

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

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Enrollment

69 participants

Start Date

Jul 22, 2020

Study Type

INTERVENTIONAL

Conditions

AL Amyloidosis

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria11

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 Criteria6

non-AL amyloidosis;
NYHA class IV;
PS-ECOG >3;
severe allergy to paramagnetic tracer;
severe claustrophobia;
pregnant or nursing women;

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

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.