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Completed

NCT Number: NCT04392960

Novel Imaging Tools in Newly-diagnosed Patients With 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.

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Key information

Conditions

AL Amyloidosis Amyloidosis Immune System Diseases Immunoglobulin Light-chain Amyloidosis Immunoproliferative Disorders Lymphoproliferative Disorders Metabolic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nutritional and Metabolic Diseases Paraproteinemias Proteostasis Deficiencies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

[18F]Florbetaben

Drug

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.

Primary outcomes

  1. 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);

  2. 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);

  3. Evaluation of the prognostic relevance of advanced imaging variables.

    Time frame: 12 months after diagnosis

    • for F-PET: myocardial uptake score.

  4. 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.

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
May 19, 2020
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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