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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: AL Amyloidosis

Treatments: Drug: [18F]Florbetaben

Study type: Interventional

Funder types: Other

Identifiers

NCT04392960

AC-015-IT

Details and patient eligibility

About

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.

Enrollment: 69 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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69 participants in 1 patient group

18F-florbetaben PET-CT scans

Experimental group

Treatment:

Drug: [18F]Florbetaben