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Molecular Imaging for Primary Amyloid Cardiomyopathy

This study is looking at new ways to see amyloid deposits in the heart using special imaging techniques. It aims to understand why the heart doesn't work well in people with primary amyloid cardiomyopathy (a heart condition caused by abnormal protein buildup). Researchers will use F-18 florbetapir/C-11 acetate PET scans, MRI scans with gadolinium contrast, and N-13 ammonia PET scans to observe changes over time. The goal is to identify mechanisms of heart dysfunction to help develop new treatments. You may be able to join if you are 18 or older and have a confirmed diagnosis of light chain amyloidosis. The study is currently unclear on its recruitment status and plans to enroll 171 participants.

Study design
This is an interventional study planning to enroll 171 participants.
What's involved
You would undergo F-18 florbetapir/C-11 acetate PET scans, MRI with gadolinium contrast, and N-13 ammonia PET scans at baseline, 6 months, and 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in F-18 florbetapir myocardial retention index and serum oxidative stress markers for 12 months, and myocardial oxidative metabolism markers for 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02641145

Molecular Imaging of Primary Amyloid Cardiomyopathy

Recruiting
NAAges 18–99InterventionalDiagnostic
Brigham and Women's Hospital
~171 participants
Updated 2025-11-14 on ClinicalTrials.gov
What's tested:F-18 florbetapir/C-11 acetate PETMRIN-13 ammonia PET

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in F-18 florbetapir myocardial retention index from baseline to 6 months and 12 months
Measured over Baseline, 6 and 12 months
+3 more outcomes measured

Conditions

Amyloidosis, Primary
Cardiomyopathy

Explore related trials

Heart FailureMultiple MyelomaPrimary Amyloidosis

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Sharmila Dorbala, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital (AHA and NIH Studies)
  • Rodney Falk, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital (NIH Study)
  • Ronglih Liao, PhD · PRINCIPAL_INVESTIGATOR · Stanford School of Medicine (AHA Study)

Who to contact

Sharmila Dorbala, MD, MPH
[email protected]
617-732-6290
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age \> 18 years
Diagnosis of light chain amyloidosis by standard criteria (immunofixation of serum and urine, IgG free light chain (FLC) assay, a biopsy of fat pad/ bone marrow, or organ biopsy, followed by typing of the light chain using immunohistochemistry or immunogold assay with confirmation by Mass spectroscopy as needed)
For subjects traveling from out of town referred for systemic AL therapy based on clinical evaluation and laboratory testing, but, pending biopsy results, study enrollment and procedures may begin before official confirmation of biopsy results. If biopsy is negative for AL amyloidosis, subject will be considered a screen failure. There will be no more than 10 subjects who fall under this screen failure for the duration of the study.
Subjects with localized amyloid deposition and non-systemic AL disease will be eligible for enrollment in group D.
Willing and able to provide consent

Exclusion

Hemodynamic instability
Decompensated heart failure (unable to lie flat for 1 hour)
Concomitant non-ischemic non-amyloid heart disease (valvular heart disease or dilated cardiomyopathy)
Known obstructive epicardial coronary artery disease with stenosis \> 50% in any single territory
Severe claustrophobia despite use of sedatives
Presence of MRI contraindications such as metallic implants (pacemaker or ICD) at the time of study enrollment except for Control Heart Failure subjects. Control HF subjects with no devices, or, with strictly MR compatible devices will be eligible to undergo MRI.
Significant renal dysfunction with estimated glomerular filtration rate \< 30 ml/min/m2 within 14 days of each cardiac MRI study. Subjects who develop renal dysfunction over the course of the study, meeting criteria listed above, will be excluded from the cardiac MRI scan except for control HF subjects. These subjects with eGFR \< 30 ml/min/1.73 m2 will undergo MRI without gadolinium contrast.
Subjects on dialysis will be excluded
Pregnant state. For women in child bearing age, a urine pregnancy test will be performed prior to the PET and the cardiac MRI studies
Documented allergy to F-18 florbetapir, C-11 acetate or gadolinium.

What this trial measures

  • Change in F-18 florbetapir myocardial retention index from baseline to 6 months and 12 monthsBaseline, 6 and 12 months

    quantitative measure of F-18 florbetapir uptake by the heart muscle

  • Change in Serum oxidative stress markers from baseline to 6 months and 12 monthsBaseline, 6 and 12 months

    serum F-2 isoprostane and peroxynitrite levels

  • Change in Myocardial oxidative metabolism markers from baseline to 6 monthsBaseline and 6 months

    K mono and coronary flow reserve obtained by C-11 acetate PET/CT at rest and stress

  • Change in Magnetic resonance imaging markers from baseline to 6 months and 12 monthsBaseline, 6 and 12 months

    Extracellular volume index, T-1 mapping, late gadolinium enhancement, global strain, left ventricular mass