65 Participants Needed

[68Ga]CBP8 PET/MRI Imaging for Cardiac Amyloidosis

VC
SD
Overseen BySharmila Dorbala, MBBS, MPH
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Brigham and Women's Hospital
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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?

SD

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

You weigh more than 300 pounds and cannot fit on the MRI table.
Any other reason determined by the investigator to be unsuitable for the study
You have had a bad reaction or allergy to gadolinium contrast dye in the past.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo [68Ga]CBP8 PET/MRI imaging to measure myocardial fibrosis

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • [68Ga]CBP8 PET/MRI
Trial Overview [68Ga]CBP8 PET/MRI imaging is being tested to see if it can measure heart fibrosis in patients with cardiac amyloidosis compared to those with other heart conditions and healthy individuals. The study aims to prove [68Ga]CBP8's effectiveness in binding interstitial collagen.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: [68Ga]CBP8 PET/MRI Amyloid SubjectsExperimental Treatment1 Intervention
Group II: [68Ga]CBP8 PET/MRI Recent Myocardial Infarction SubjectsActive Control1 Intervention
Group III: [68Ga]CBP8 PET/MRI Hypertrophic Cardiomyopathy SubjectsActive Control1 Intervention
Group IV: [68Ga]CBP8 PET/MRI Healthy ControlsPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Published Research Related to This Trial

In a pilot study of 12 patients, F18-florbetapir PET imaging showed radiotracer uptake in the myocardium of all participants, indicating its potential for visualizing cardiac amyloid fibrils, although the uptake was non-specific.
The highest uptake values were observed in a patient already diagnosed with transthyretin cardiac amyloidosis, while at-risk patients and controls showed similar uptake levels, suggesting that further research is needed to refine PET imaging protocols for early detection of cardiac amyloidosis.
Pilot Study of F18-Florbetapir in the Early Evaluation of Cardiac Amyloidosis.Sperry, BW., Bock, A., DiFilippo, FP., et al.[2021]
In a study of 18 patients with transthyretin-familial amyloid polyneuropathy, both (99m)Tc-diphosphonate imaging and cardiac MRI with late gadolinium enhancement were effective in detecting myocardial amyloid deposition, but (99m)Tc-diphosphonate imaging identified a greater extent of amyloid infiltration.
The findings suggest that while both imaging techniques are valuable, (99m)Tc-diphosphonate imaging may provide a more accurate assessment of cardiac amyloid burden compared to MRI, which could lead to underestimation of the condition.
Comparison between (99m)Tc-diphosphonate imaging and MRI with late gadolinium enhancement in evaluating cardiac involvement in patients with transthyretin familial amyloid polyneuropathy.Minutoli, F., Di Bella, G., Mazzeo, A., et al.[2015]
In a study of 27 patients suspected of having cardiac amyloidosis, 18F-NaF PET/MRI demonstrated good diagnostic performance, particularly when using semi-quantitative measures like myocardium-to-blood pool (M/B) ratios to differentiate between types of cardiac amyloidosis.
The study found that M/B ratios were significantly higher in transthyretin (TTR) cardiac amyloidosis compared to light-chain (AL) and no cardiac amyloidosis, indicating that while 18F-NaF PET/MRI can effectively assess amyloid load, visual interpretation may be challenging in routine clinical practice.
18F-sodium fluoride PET/MRI myocardial imaging in patients with suspected cardiac amyloidosis.Abulizi, M., Sifaoui, I., Wuliya-Gariepy, M., et al.[2022]

Citations

Molecular Imaging of Myocardial Fibrosis in Cardiac ...The investigators hypothesize that [68Ga]CBP8 uptake will be greater in patients with cardiac amyloidosis, myocardial fibrosis, and hypertrophic ...
Molecular Imaging of Myocardial Fibrosis in Cardiac ...The aim of this study is also to correlate [68Ga]CBP8 PET uptake with standard MRI measures in patients with cardiac amyloidosis. Read more ...
Molecular Imaging of Myocardial Fibrosis in Cardiac ...The investigators hypothesize that [68Ga]CBP8 uptake will be greater in patients with cardiac amyloidosis, myocardial fibrosis, and hypertrophic ...
[68Ga]CBP8 PET/MRI Imaging for Cardiac AmyloidosisThis suggests that [68Ga]CBP8 PET/MRI could be effective in providing detailed images to aid in the diagnosis and management of cardiac amyloidosis.
Feasibility of 68Ga-Labeled Fibroblast Activation Protein ...In a study involving 30 patients with biopsy-proven systemic light-chain amyloidosis, [ 68 Ga]Ga-FAPI-04 PET/CT was used to assess cardiac ...
Molecular Imaging of Myocardial Fibrosis in Cardiac ...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.
Trial | NCT05619302The aim of this proposed research study is, using simultaneous PET/MRI imaging, to determine whether \[68Ga\]CBP8 uptake will accurately identify and quantify ...
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