New PET scan could reveal hidden heart scarring in rare disease
NCT ID NCT05619302
First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times
Summary
This study tested whether a special PET imaging probe called [68Ga]CBP8 can measure scarring (fibrosis) in the hearts of people with cardiac amyloidosis, a rare condition where abnormal proteins build up in the heart. Researchers compared 18 participants with cardiac amyloidosis to people with other heart conditions and healthy volunteers. The goal was to see if the probe binds to collagen and helps doctors better understand heart damage, not to provide a treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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18 people
The number who actually took part.
- Started
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Jan 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for AL-amyloid subjects: * Age \> 18 years * Willing and able to provide consent * AL-CA: Diagnosis of systemic light chain amyloidosis by standard criteria: Immunofixation of serum, serum free light chain (FLC) assay, a biopsy of fat pad/bone marrow, or organ biopsy, followed by typing of the light chain using immunohistochemistry or immunogold assay with confirmation by mass spectroscopy as needed AND * Proof of cardiac involvement by AL amyloidosis * Abnormal cardiac biomarkers: abnormal high sensitivity TnT 5th generation levels (\> 15 ng/L) or abnormal age-appropriate NT-proBNP (abnormal values: \< 50 years: \> 450 pg/ml; 50-75 years: \> 900 pg/ml; \> 75 years: \> 1800 pg/ml) OR * Abnormal echocardiogram (wall thickness \> 12 mm in the absence of other causes of increased LV wall thickness) OR * Abnormal CMR (wall thickness \> 12 mm, extracellular volume \> 0.40 or typical CMR appearance of cardiac amyloidosis with difficulty nulling images and non-coronary distribution late gadolinium enhancement) OR * Positive endomyocardial biopsy Inclusion Criteria for ATTR-amyloid subjects: * Age \> 18 years * Willing and able to provide consent * ATTR-CA: Diagnosis of either wildtype or hereditary transthyretin cardiac amyloidosis by standard criteria: Endomyocardial biopsy followed by typing of the transthyretin amyloidosis using immunohistochemistry or immunogold assay with confirmation by mass spectroscopy as needed * Extracardiac biopsy with typical cardiac imaging findings * Hereditary ATTR amyloidosis by genetic testing OR * Grade 2 or grade 3 myocardial uptake of 99mTc-PYP if AL amyloidosis is excluded Inclusion Criteria for recent myocardial infarction subjects: * Age \> 18 years * Willing and able to provide consent * Recent MI: Diagnosis of recent type 1 myocardial infarction by standard criteria * More than 6 weeks from diagnosis of MI but within 6 months * Imaging evidence of loss of viable myocardium or persistent regional wall motion abnormalities in a pattern consistent with an ischemic etiology in more than one segment Inclusion Criteria for hypertrophic cardiomyopathy subjects: * Age \> 18 years * Willing and able to provide consent * Hypertrophic cardiomyopathy: Diagnosis of hypertrophic cardiomyopathy by standard criteria * MRI evidence of late gadolinium enhancement Inclusion Criteria for recent healthy control subjects: * Age \> 18 years * Willing and able to provide consent * No known cardiac amyloidosis or recent myocardial infarction Exclusion Criteria: * Dialysis * NYHA (New York Heart Association) Class IV * Acute myocardial infarction within 6 weeks * Pregnancy or nursing * History of adverse events from or allergy to gadolinium contrast media * Hemodynamic instability * Severe claustrophobia despite use of sedatives * Decompensated heart failure (unable to lie flat for 1 hour) * Concomitant clinically significant non-ischemic non-amyloid heart disease (valvular heart disease or dilated cardiomyopathy) * Body weight over limit for MRI table (\>300 lbs) * Contraindications for MRI (including non-compatible cardiac implantable electronic devices, drug infusion pumps, and metallic or electric implants) * Any other reason determined by the investigator to be unsuitable for the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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