[68Ga]CBP8 PET/MRI Imaging for Cardiac Amyloidosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to image heart fibrosis (scarring) using a PET/MRI technique with a special probe called [68Ga]CBP8. The goal is to determine if this probe can better detect heart scarring in individuals with cardiac amyloidosis, a condition where abnormal proteins accumulate in the heart. The trial also includes participants who recently experienced a heart attack and those with hypertrophic cardiomyopathy (a disease causing heart muscle thickening) to compare results. Individuals with known cardiac amyloidosis, recent heart attacks, or hypertrophic cardiomyopathy may be eligible to participate. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in heart imaging.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that [68Ga]CBP8 PET/MRI is safe for cardiac imaging?
Research is investigating how well [68Ga]CBP8 can measure heart fibrosis, which involves the thickening or scarring of heart tissue. This substance undergoes testing in PET/MRI scans to assess its safety and effectiveness. Although specific safety details for [68Ga]CBP8 are unavailable, the trial's later stage suggests earlier studies found it safe.
Typically, later-stage trials indicate the treatment is considered safe with manageable side effects. However, every treatment carries some risks. Prospective participants should discuss potential side effects with the research team.12345Why are researchers excited about this trial?
Researchers are excited about using [68Ga]CBP8 PET/MRI imaging for cardiac amyloidosis because it offers a unique way to visualize amyloid deposits in the heart. Unlike standard imaging techniques that may not be as sensitive or specific, this method combines the precision of PET with MRI to provide detailed insights into the extent and impact of the disease. Additionally, [68Ga]CBP8 is a novel tracer that binds specifically to amyloid proteins, potentially allowing for earlier and more accurate detection compared to traditional diagnostic methods. This could lead to better-targeted treatments and improved outcomes for patients with cardiac amyloidosis.
What evidence suggests that [68Ga]CBP8 PET/MRI is effective for measuring fibrosis in cardiac amyloidosis?
Research has shown that a new imaging method, \[68Ga\]CBP8 PET/MRI, could help identify and measure heart tissue scarring, particularly in conditions like cardiac amyloidosis. In this trial, participants will undergo \[68Ga\]CBP8 PET/MRI to evaluate its effectiveness in various conditions. Previous studies have demonstrated higher activity in patients with cardiac amyloidosis, indicating effective attachment to collagen, a marker of scarring. This technique might provide clearer images and aid in better diagnosing and managing heart issues related to scarring. Early results also suggest that \[68Ga\]CBP8 activity aligns well with standard MRI results, supporting its potential usefulness. This could lead to more accurate evaluations of heart conditions, especially those involving scarring.12567
Who Is on the Research Team?
Sharmila Dorbala, MBBS, MPH
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
This trial is for adults over 18 with cardiac amyloidosis, recent myocardial infarction, or hypertrophic cardiomyopathy. Healthy adults can also join as controls. Exclusions include pregnancy, severe claustrophobia, weight over MRI limit, heart failure that prevents lying flat, NYHA Class IV status, and certain contraindications to MRI.Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Imaging
Participants undergo [68Ga]CBP8 PET/MRI imaging to measure myocardial fibrosis
Follow-up
Participants are monitored for safety and effectiveness after imaging
What Are the Treatments Tested in This Trial?
Interventions
- [68Ga]CBP8 PET/MRI
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor