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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04392960
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : May 5, 2022
Sponsor:
Information provided by (Responsible Party):
GIOVANNI PALLADINI, IRCCS Policlinico S. Matteo

Study Description
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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.

Condition or disease Intervention/treatment Phase
AL Amyloidosis Drug: [18F]Florbetaben Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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
Actual Study Start Date : July 22, 2020
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04392960


Contacts
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Contact: Giovanni Palladini, MD, PhD +390382502994 segreteria.amiloidosi@smatteo.pv.it
Contact: Anna Carnevale Baraglia +390382502994 a.carnevalebaraglia@smatteo.pv.it

Locations
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Italy
Fondazione IRCCS Policlinico San Matteo Recruiting
Pavia, Italy, 27100
Contact: Giovanni Palladini         
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
More Information
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Publications:

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Responsible Party: GIOVANNI PALLADINI, Principal Investigator, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT04392960    
Other Study ID Numbers: AC-015-IT
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GIOVANNI PALLADINI, IRCCS Policlinico S. Matteo:
Amyloidosis
Prognosis
[18F]Florbetaben
Additional relevant MeSH terms:
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Immunoglobulin Light-chain Amyloidosis
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Paraproteinemias