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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04392960

Enrollment

Registered

2020-05-19

Start date

2020-07-22

Completion date

2025-06-30

Last updated

2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AL Amyloidosis

Keywords

Amyloidosis, Prognosis, [18F]Florbetaben

Brief 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.

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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;

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of the prognostic relevance of advanced imaging variables.	12 months after diagnosis	\- for CMR: T1, T2, ECV, indexed volumes, mass, ejection fraction (EF);
Evaluation of advanced imaging variables in response assessment.	6 months after initiation of chemotherapy targeting the amyloid plasma cell clone	The same variables considered at baseline will be measured 6 months after initiation of chemotherapy targeting the amyloid plasma cell clone. Changes in these variables compared to baseline will be considered.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026