Using I-124 evuzamitide to diagnose cardiac amyloidosis

A Phase 3, Open-Label, Multicenter Study of I-124 Evuzamitide as an Imaging Agent for the Diagnosis of Cardiac Amyloidosis Using Positron Emission Tomography Computed Tomography (PET/CT)

This study is testing a new radioactive dye called I-124 evuzamitide to see if it can help doctors diagnose cardiac amyloidosis in people who might have the condition.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Brigham and Women's Hospital (Academic / other)
• Locations: 12 sites (Duarte, California and 11 other locations)
• Trial ID: NCT06788535 on ClinicalTrials.gov

What this trial studies

This Phase 3, open label, single dose imaging study aims to evaluate the efficacy and safety of I-124 evuzamitide, a radioactive dye, for diagnosing cardiac amyloidosis in participants suspected of having the condition. Participants will receive a single dose of I-124 evuzamitide prior to undergoing a Positron Emission Tomography Computed Tomography (PET/CT) scan. The study will enroll approximately 200 participants and will last up to 60 days, focusing on the effectiveness of this imaging agent in identifying cardiac amyloidosis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are suspected of having cardiac amyloidosis and are undergoing diagnostic evaluations for the condition.

Not a fit: Patients who do not have suspected cardiac amyloidosis or those who cannot undergo PET/CT imaging will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of diagnosing cardiac amyloidosis, leading to better patient management and treatment outcomes.

How similar studies have performed: Other studies have shown promise in using imaging agents for diagnosing amyloidosis, but the specific use of I-124 evuzamitide is novel.

Eligibility criteria

Inclusion Criteria:

* 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., echocardiography, CMR, bone avid tracer cardiac SPECT, extracardiac or endomyocardial biopsy, etc.). Participants can 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

Exclusion Criteria:

* Established diagnosis of cardiac amyloidosis.
* Established diagnosis of systemic amyloidosis (e.g., renal AL or ATTR peripheral neuropathy) without known cardiac involvement. Participants who are amyloid positive only with carpal tunnel tissue or laminectomy 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: Patients may enter the screening period of a clinical trial for treatment after the ICF is signed and participant is enrolled in this trial but 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 potassium iodide.
* Receiving hemodialysis or peritoneal dialysis.
* eGFR less than 15mL/min/1.73m2.
* Myocardial infarction within three (3) months of screening.
* Has severe claustrophobia or any condition, medial 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 seven (7) days prior to I-124 evuzamitide administration.
* Known uncorrected thyroid disorders (other than mild elevation of thyroid stimulating hormone with normal T4).

Where this trial is running

Duarte, California and 11 other locations

• City of Hope - Duarte — Duarte, California, United States (Not_yet_recruiting)
• Yale Cardiovascular Medicine — New Haven, Connecticut, United States (Not_yet_recruiting)
• Northwestern University — Chicago, Illinois, United States (Not_yet_recruiting)
• Cook County Health — Chicago, Illinois, United States (Not_yet_recruiting)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
• St. Lukes (CVIT) Saint Luke's Health System — Kansas City, Missouri, United States (Not_yet_recruiting)
• Washington University of St. Louis — St. Louis, Missouri, United States (Not_yet_recruiting)
• Columbia University — New York, New York, United States (Not_yet_recruiting)
• Duke University — Durham, North Carolina, United States (Not_yet_recruiting)
• Oregon Health and Science University — Portland, Oregon, United States (Not_yet_recruiting)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Sharmila Dorbala, MD, MPH, MASNC

Conditions Cardiac Amyloidosis; Amyloid Light Chain; Amyloidosis; Amyloid Transthyretin; Transthyretin; REVEAL; PET Imaging