Clinical trial
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
Name
AC-015-IT
Description
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.
Trial arms
Trial start
2020-07-22
Estimated PCD
2025-02-28
Trial end
2025-02-28
Status
Recruiting
Treatment
[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.
Arms:
18F-florbetaben PET-CT scans
Size
69
Primary endpoint
Evaluation of the prognostic relevance of advanced imaging variables.
12 months after diagnosis
Evaluation of the prognostic relevance of advanced imaging variables.
12 months after diagnosis
Evaluation of the prognostic relevance of advanced imaging variables.
12 months after diagnosis
Evaluation of advanced imaging variables in response assessment.
6 months after initiation of chemotherapy targeting the amyloid plasma cell clone
Eligibility 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;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 69, 'type': 'ESTIMATED'}}
Updated at
2023-06-06
1 organization
1 product
1 indication
Organization
IRCCS Policlinico S. MatteoProduct
[18F]FlorbetabenIndication
AL Amyloidosis