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Molecular Imaging Probe

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

Q: Is [68Ga]CBP8 PET/MRI Amyloid Subjects a reliable procedure for individuals?

<p>Our experts at Power judged the safety of [68Ga]CBP8 PET/<a href="https://www.withpower.com/clinical-trials/mri">MRI</a> Amyloid Subjects to be a 3, due to its Phase 3 classification which means there is evidence showing its efficacy and multiple test results that verify its security.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Extracellular volume from clinically performed simultaneous cardiac MRI

Mean Standardized Uptake Value (SUVmean) of [68Ga]CBP8 uptake in the heart

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,616 Previous Clinical Trials

11,470,883 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many study participants are actively engaging with this research?

"Affirmative. The information hosted on clinicaltrials.gov indicates that this medical study is actively recruiting patients, having been initially posted on March 1st 2023 and last updated July 25th 2023. 65 participants are needed across a single trial site."

Answered by AI

Is [68Ga]CBP8 PET/MRI Amyloid Subjects a reliable procedure for individuals?

"Our experts at Power judged the safety of [68Ga]CBP8 PET/MRI Amyloid Subjects to be a 3, due to its Phase 3 classification which means there is evidence showing its efficacy and multiple test results that verify its security."

Answered by AI

Are participants still enrolling for this research project?

"Affirmative. Clinicaltrials.gov evidences that this clinical trial, which was originally published on the 3rd of January 2023, is actively enrolling participants. 65 participants are needed to be recruited from 1 medical site."

Answered by AI

Recent research and studies

American Journal of Respiratory and Critical Care MedicineJournal

Type I Collagen–targeted Positron Emission Tomography Imaging in Idiopathic Pulmonary Fibrosis: First-in-human Studies

Montesi, Sydney B., David Izquierdo-Garcia, Pauline Désogère, Eric Abston, Lloyd L. Liang, Subba Digumarthy, Ravi Seethamraju, Michael Lanuti, Peter Caravan, and Ciprian Catana. 2019. “Type I Collagen–targeted Positron Emission Tomography Imaging in Idiopathic Pulmonary Fibrosis: First-in-human Studies”. American Journal of Respiratory and Critical Care Medicine. American Thoracic Society. doi:10.1164/rccm.201903-0503le.

Science Translational MedicineJournal

Type I Collagen–targeted PET Probe for Pulmonary Fibrosis Detection and Staging in Preclinical Models

Désogère, Pauline, Luis F. Tapias, Lida P. Hariri, Nicholas J. Rotile, Tyson A. Rietz, Clemens K. Probst, Francesco Blasi, et al.. 2017. “Type I Collagen–targeted PET Probe for Pulmonary Fibrosis Detection and Staging in Preclinical Models”. Science Translational Medicine. American Association for the Advancement of Science (AAAS). doi:10.1126/scitranslmed.aaf4696.

Journal of Nuclear MedicineJournal

Optimization of a Collagen-targeted PET Probe for Molecular Imaging of Pulmonary Fibrosis

Désogère, Pauline, Luis F. Tapias, Tyson A. Rietz, Nicholas Rotile, Francesco Blasi, Helen Day, Justin Elliott, Bryan C. Fuchs, Michael Lanuti, and Peter Caravan. 2017. “Optimization of a Collagen-targeted PET Probe for Molecular Imaging of Pulmonary Fibrosis”. Journal of Nuclear Medicine. Society of Nuclear Medicine. doi:10.2967/jnumed.117.193532.

clinicaltrials.govStudy