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Molecular Imaging Probe

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

Phase 3
Recruiting
Led By Sharmila Dorbala, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
AL-amyloid subjects: Age > 18 years, willing and able to provide consent, diagnosis of systemic light chain amyloidosis by standard criteria, proof of cardiac involvement by AL amyloidosis
Recent healthy control subjects: Age > 18 years, willing and able to provide consent, no known cardiac amyloidosis or recent myocardial infarction
Must not have
NYHA (New York Heart Association) Class IV
Dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
Pivotal Trial

Summary

This trial will measure if a PET/MRI probe can detect heart fibrosis in people with cardiac amyloidosis. It will also compare the PET/MRI probe with standard MRI measures in people with and without heart disease.

Who is the study for?
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.
What is being tested?
[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.
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions related to the PET/MRI procedure such as discomfort from lying still during imaging or allergic reactions to contrast media used during the scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18, can consent, and have AL amyloidosis with heart involvement.
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I am over 18, can consent, and don't have heart amyloidosis or recent heart attack.
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I am over 18, had a heart attack between 6 weeks and 6 months ago, and have heart damage shown on scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart condition severely limits my physical activity.
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I am on dialysis.
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I cannot lie flat for an hour due to heart failure.
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My blood pressure and heart rate are stable.
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I have had a heart attack in the last 6 weeks.
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I experience severe claustrophobia even with sedatives.
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I have a serious heart condition that is not related to blocked arteries or amyloid.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Extracellular volume from clinically performed simultaneous cardiac MRI
Mean Standardized Uptake Value (SUVmean) of [68Ga]CBP8 uptake in the heart

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: [68Ga]CBP8 PET/MRI Amyloid SubjectsExperimental Treatment1 Intervention
Individuals with documented cardiac amyloidosis will undergo \[68Ga\]CBP8 PET/MRI.
Group II: [68Ga]CBP8 PET/MRI Recent Myocardial Infarction SubjectsActive Control1 Intervention
Individuals with recent myocardial infarction will undergo \[68Ga\]CBP8 PET/MRI.
Group III: [68Ga]CBP8 PET/MRI Hypertrophic Cardiomyopathy SubjectsActive Control1 Intervention
Individuals with hypertrophic cardiomyopathy will undergo \[68Ga\]CBP8 PET/MRI.
Group IV: [68Ga]CBP8 PET/MRI Healthy ControlsPlacebo Group1 Intervention
Individuals without documented cardiovascular disease will undergo \[68Ga\]CBP8 PET/MRI.

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,841,559 Total Patients Enrolled
2 Trials studying Cardiac Amyloidosis
93 Patients Enrolled for Cardiac Amyloidosis
Sharmila Dorbala, MDPrincipal InvestigatorBrigham and Women's Hospital
2 Previous Clinical Trials
241 Total Patients Enrolled
1 Trials studying Cardiac Amyloidosis
70 Patients Enrolled for Cardiac Amyloidosis

Media Library

[68Ga]CBP8 PET/MRI (Molecular Imaging Probe) Clinical Trial Eligibility Overview. Trial Name: NCT05619302 — Phase 3
Cardiac Amyloidosis Research Study Groups: [68Ga]CBP8 PET/MRI Amyloid Subjects, [68Ga]CBP8 PET/MRI Recent Myocardial Infarction Subjects, [68Ga]CBP8 PET/MRI Healthy Controls, [68Ga]CBP8 PET/MRI Hypertrophic Cardiomyopathy Subjects
Cardiac Amyloidosis Clinical Trial 2023: [68Ga]CBP8 PET/MRI Highlights & Side Effects. Trial Name: NCT05619302 — Phase 3
[68Ga]CBP8 PET/MRI (Molecular Imaging Probe) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05619302 — Phase 3
~16 spots leftby Jun 2025
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