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

June 5, 2023 updated by: GIOVANNI PALLADINI, IRCCS Policlinico S. Matteo

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo
        • Contact:
          • Giovanni Palladini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-florbetaben PET-CT scans
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the prognostic relevance of advanced imaging variables.
Time Frame: 12 months after diagnosis
- for CMR: T1, T2, ECV, indexed volumes, mass, ejection fraction (EF);
12 months after diagnosis
Evaluation of the prognostic relevance of advanced imaging variables.
Time Frame: 12 months after diagnosis
- for echocardiography: left ventricular wall thickness (mLVW), EF, 2D-GLS, midwall fractional shortening (mFS), and stroke volume index (SVI);
12 months after diagnosis
Evaluation of the prognostic relevance of advanced imaging variables.
Time Frame: 12 months after diagnosis
- for F-PET: myocardial uptake score.
12 months after diagnosis
Evaluation of advanced imaging variables in response assessment.
Time Frame: 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.
6 months after initiation of chemotherapy targeting the amyloid plasma cell clone

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Matteo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2020

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

February 27, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (Actual)

May 19, 2020

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-015-IT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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