RECRUITING

Molecular Imaging of Myocardial Fibrosis in Cardiac Amyloidosis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary aim of our pilot study is to determine whether fibrosis in the heart can be measured with \[68Ga\]CBP8, a positron emission tomography (PET) probe, using PET/magnetic resonance imaging (MRI) imaging, in 30 individuals with documented cardiac amyloidosis. The investigators will also enroll 15 individuals with recent myocardial infarction and 15 individuals with hypertrophic cardiomyopathy as positive controls for fibrosis, and the investigators will enroll 5 individuals without cardiovascular disease to undergo \[68Ga\]CBP8 PET/MRI imaging as a healthy control group. The primary hypothesis of this study is that \[68Ga\]CBP8 will bind to interstitial collagen and quantify myocardial fibrosis in patients with cardiac amyloidosis. The investigators hypothesize that \[68Ga\]CBP8 uptake will be greater in patients with cardiac amyloidosis, myocardial fibrosis, and hypertrophic cardiomyopathy than in healthy controls. Secondly, the investigators also hypothesize that \[68Ga\]CBP8 activity more strongly correlates with standard MRI measures in patients with recent myocardial infarction and hypertrophic cardiomyopathy (where extracellular expansion is caused by myocardial fibrosis/collagen deposition) than in patients with cardiac amyloidosis (where myocardial fibrosis is combined with infiltration).

Official Title

Molecular Imaging of Myocardial Fibrosis in Cardiac Amyloidosis

Quick Facts

Study Start:2023-01-03
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05619302

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Dialysis
  2. * NYHA (New York Heart Association) Class IV
  3. * Acute myocardial infarction within 6 weeks
  4. * Pregnancy or nursing
  5. * History of adverse events from or allergy to gadolinium contrast media
  6. * Hemodynamic instability
  7. * Severe claustrophobia despite use of sedatives
  8. * Decompensated heart failure (unable to lie flat for 1 hour)
  9. * Concomitant clinically significant non-ischemic non-amyloid heart disease (valvular heart disease or dilated cardiomyopathy)
  10. * Body weight over limit for MRI table (\>300 lbs)
  11. * Contraindications for MRI (including non-compatible cardiac implantable electronic devices, drug infusion pumps, and metallic or electric implants)
  12. * Any other reason determined by the investigator to be unsuitable for the study

Contacts and Locations

Study Contact

Vaidehi Chemburkar, MS
CONTACT
617-732-6647
vchemburkar@bwh.harvard.edu

Principal Investigator

Sharmila Dorbala, MD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Sharmila Dorbala, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

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 Registration Dates

Study Start Date2023-01-03
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2023-01-03
Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

  • Amyloidosis
  • Cardiac
  • Heart
  • Imaging
  • Diagnosis

Additional Relevant MeSH Terms

  • Cardiac Amyloidosis