Overview

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

Status:
Recruiting
Trial end date:
2023-02-28
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
IRCCS Policlinico S. Matteo
Criteria
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;