REVEAL - Research With I-124 EVuzamitide to Elucidate Cardiac AmyLoidosis

Completed · Phase 3

Conditions studied: Cardiac Amyloidosis

In brief

The purpose of this multicenter, open-label, single-arm, single-dose study is to assess the sensitivity and specificity of I-124 evuzamitide for the diagnosis of cardiac amyloidosis compared to current clinical standards for diagnosis of cardiac amyloidosis. Participants will receive a positron emission tomography computed tomography (PET/CT) scan 4 hours (± 60 minutes) after administration of I-124 evuzamitide. The primary study hypotheses are that the sensitivity and specificity of I-124 evuzamitide PET/CT imaging of cardiac amyloidosis will be greater than 65% and 55%, respectively, in participants with suspected cardiac amyloidosis.

Key facts

Study ID: NCT06788535
Run by: Sharmila Dorbala
People needed: 204
Starts: 2025-01-14
Expected to finish: 2026-04-09
Last updated by the study team: 2026-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Understands the study procedures and can give signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Male or female ≥18 years of age.
Is suspected of having cardiac amyloidosis and is undergoing or will undergo a diagnostic evaluation for cardiac amyloidosis (e.g., echocardiogram [ECHO], cardiac magnetic resonance imaging [CMR], bone-avid tracer cardiac single-photon emission computerized tomography (SPECT), extracardiac biopsy, or endomyocardial biopsy [EMB]). Participants may be enrolled before or during their diagnostic evaluation for cardiac amyloidosis.
Able to undergo PET/CT imaging as part of the study, including ability to lie supine for approximately 1 hour.
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 30 days after administration of I-124 evuzamitide.
For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm during the treatment period and for at least 120 days after the last dose of study intervention.

You may not qualify if…

Established diagnosis of cardiac amyloidosis.
Established diagnosis of systemic amyloidosis with known organ involvement (e.g., renal AL or ATTR peripheral neuropathy). Participants who are amyloid positive only from peripheral tissue, such as abdominal fat, carpal tunnel tissue, or laminectomy tissue, are allowed as long as they do not have other known organ involvement.
Receiving therapy with an approved treatment (e.g., tafamadis) or in a clinical trial for treatment for ATTR cardiac amyloidosis at time of enrollment. For AL and ATTR amyloidosis: Patients may enter the screening period of a clinical trial for treatment after the ICF is signed and they are enrolled in this trial, but they may not receive an experimental therapy until after the Day 30 safety follow-up visit in this trial.
Is pregnant or breast-feeding.
Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis.
Has a known allergy to KI.
Receiving hemodialysis or peritoneal dialysis.
Estimated glomerular filtration rate (eGFR) less than 15 mL/min/1.73 m\^2.
Myocardial infarction within 3 months of screening.
Has severe claustrophobia or any condition, medical or otherwise, that would prevent completion of the study assessments.
Has any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the participant.
Has received heparin or heparin analogs (e.g., enoxaparin, dalteparin, fondaparinux) within 7 days prior to I-124 evuzamitide administration.
Known uncorrected thyroid disorders (other than mild elevation of thyroid stimulating hormone with normal thyroxine [T4]).

Where it is running

Mayo Clinic — Scottsdale, Arizona, United States
City of Hope - Duarte — Duarte, California, United States
University of California — San Francisco, California, United States
Yale Cardiovascular Medicine — New Haven, Connecticut, United States
Cleveland Clinic — Weston, Florida, United States
Northwestern University — Chicago, Illinois, United States
Cook County Health — Chicago, Illinois, United States
Brigham and Women's Hospital — Boston, Massachusetts, United States
Mayo Clinic — Rochester, Minnesota, United States
St. Lukes (CVIT) Saint Luke's Health System — Kansas City, Missouri, United States
Washington University of St. Louis — St Louis, Missouri, United States
Rutgers — New Brunswick, New Jersey, United States
Columbia University — New York, New York, United States
Duke University — Durham, North Carolina, United States
Cone Health — Greensboro, North Carolina, United States
Cleveland Clinic — Cleveland, Ohio, United States
Oregon Health and Science University — Portland, Oregon, United States
Medical University of South Carolina — Charleston, South Carolina, United States
Houston Methodist — Houston, Texas, United States
Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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