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COMPLETED
NCT06788535
PHASE3

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

Sponsor: Sharmila Dorbala

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

204

Start Date

2025-01-14

Completion Date

2026-04-09

Last Updated

2026-04-30

Healthy Volunteers

No

Interventions

DRUG

I-124 evuzamitide

A single dose of 1 mCi (± 10%) I-124 evuzamitide administered intravenously.

Locations (20)

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