Research With I-124 EVuzamitide to Elucidate Cardiac AmyLoidosis

Last updated: March 28, 2025
Sponsor: Sharmila Dorbala
Overall Status: Active - Recruiting

Phase

3

Condition

Amyloidosis

Treatment

I-124 evuzamitide

Clinical Study ID

NCT06788535
2024P002136
  • Ages > 18
  • All Genders

Study Summary

The purpose of this Phase 3, open label, single dose imaging study is to evaluate the efficacy and safety of I-124 evuzamitide (radioactive dye) for diagnosing Cardiac Amyloidosis in participants with suspected Cardiac Amyloidosis. The imaging test that will be used in this study is a Positron Emission Tomography Computed Tomography (PET/CT) scan.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Understands the study procedures and can give signed informed consent which includescompliance with the requirements and restrictions listed in the informed consentform (ICF) and in this protocol.

  • Male or female ≥18 years of age.

  • Is suspected of having cardiac amyloidosis and is undergoing or will undergo adiagnostic evaluation for cardiac amyloidosis (e.g., echocardiography, CMR, boneavid tracer cardiac SPECT, extracardiac or endomyocardial biopsy, etc.).Participants can be enrolled before or during their diagnostic evaluation forcardiac amyloidosis.

  • Able to undergo PET/CT imaging as part of the study, including ability to lie supinefor approximately 1 hour.

  • For women of childbearing potential: agreement to remain abstinent (refrain fromheterosexual intercourse) or use contraceptive methods that result in a failure rateof <1% per year during the treatment period and for at least 30 days afteradministration of I-124 evuzamitide.

  • For men: agreement to remain abstinent or use contraceptive measures and agreementto refrain from donating sperm

Exclusion

Exclusion Criteria:

  • Established diagnosis of cardiac amyloidosis.

  • Established diagnosis of systemic amyloidosis (e.g., renal AL or ATTR peripheralneuropathy) without known cardiac involvement. Participants who are amyloid positiveonly with carpal tunnel tissue or laminectomy are allowed as long as they do nothave other known organ involvement.

  • Receiving therapy with an approved treatment (e.g., tafamadis) or in a clinicaltrial for treatment for ATTR cardiac amyloidosis at time of enrollment. For AL andATTR: Patients may enter the screening period of a clinical trial for treatmentafter the ICF is signed and participant is enrolled in this trial but may notreceive an experimental therapy until after the Day 30 safety follow-up visit inthis trial.

  • Is pregnant or breast-feeding.

  • Is mentally or legally incapacitated, has significant emotional problems at the timeof 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 preventcompletion of the study assessments.

  • Has any illness that, in the opinion of the investigator, might confound the resultsof 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 thyroidstimulating hormone with normal T4).

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: I-124 evuzamitide
Phase: 3
Study Start date:
January 14, 2025
Estimated Completion Date:
December 31, 2025

Study Description

This Phase 3, open label, single dose study will evaluate the efficacy and safety of I-124 evuzamitide when administered as a single dose prior to a PET/CT scan. Participants will be in the study for up to 60 days and approximately 200 participants with suspected Cardiac Amyloidosis will be enrolled.

Connect with a study center

  • City of Hope - Duarte

    Duarte, California 91010
    United States

    Site Not Available

  • Yale Cardiovascular Medicine

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Cook County Health

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • St. Lukes (CVIT) Saint Luke's Health System

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Washington University of St. Louis

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Columbia University

    New York, New York 10032
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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