Molecular Imaging of Primary Amyloid Cardiomyopathy

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT02641145
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • F-18 florbetapir/C-11 acetate PET — RADIATION
    F-18 florbetapir PET scan, C-11 acetate PET scan
  • MRI — DEVICE
    Cardiac MRI with gadolinium contrast.
  • N-13 ammonia PET — RADIATION
    N-13 ammonia PET scan following supine bicycle stress.

Study Details

Cardiac amyloidosis is a major cause of early treatment-related death and poor overall survival in individuals with systemic light chain amyloidosis. This project will develop a novel approach to visualize cardiac amyloid deposits using advanced imaging methods. The long-term goal of this work is to identify the mechanisms of cardiac dysfunction, in order to guide the development of novel life-saving treatments.

Key Dates

Start date
Apr 1, 2016
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
171 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Active AL cardiac amyloidosis
    75 individuals with light chain systemic amyloidosis with active plasma cell dyscrasia and cardiac involvement will undergo a research F-18 florbetapir PET, C-11 acetate PET, and MRI of blood of the heart, as well as the heavy metal analysis of the blood at baseline, 6 months and 12 months after initiation of chemotherapy. 25 of these individuals will also undergo a N-13 ammonia PET scan of the heart following supine bicycle stress at baseline and at 6 months after initiation of chemotherapy.
  • Active Comparator: Remission AL cardiac amyloidosis
    25 individuals with light chain systemic amyloidosis with cardiac involvement and plasma cell dyscrasia in hematological remission (complete hematological remission or very good partial response-differential free light chain (dFLC)\<40 mg/dL for \> 1 year prior to enrollment) will undergo a research F-18 florbetapir PET, C-11 acetate PET, and MRI scan of the heart as well as a heavy metal analysis of the blood at baseline.
  • Experimental: Active AL Pre-CMP
    36 individuals with light chain systemic amyloidosis with active plasma cell dyscrasia and without cardiac involvement will undergo a research F-18 florbetapir PET, C-11 acetate PET, and MRI of the heart, as well as a heavy metal analysis of the blood at baseline. At 6 months they will undergo a research MRI of the heart and at 12 months they will have a clinical follow up. Subjects with contraindications to Cardiac MRI or gadolinium contrast may still be eligible for study participation.
  • No Intervention: Multiple Myeloma Controls
    25 individuals with diagnosis of multiple myeloma without concomitant amyloidosis by standard criteria will undergo urine and blood testing only.
  • Experimental: Heart Failure
    10 individuals with diagnosis of heart failure without amyloidosis by standard criteria will undergo a research F-18 florbetapir PET, C-11 acetate PET, and MRI of the heart, as well as a heavy metal analysis of the blood at baseline..

Primary Outcome Measure

Change in F-18 florbetapir myocardial retention index from baseline to 6 months and 12 months [ Time Frame: Baseline, 6 and 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Womens' HospitalBostonMassachusetts02421
Sharmila Dorbala
[email protected]
Sharmila Dorbala, MBBS (PRINCIPAL_INVESTIGATOR)

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By research site
Brigham and Womens' Hospital· Boston, MA

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