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ACTIVE NOT RECRUITING
NCT06788535
PHASE3

Research With I-124 EVuzamitide to Elucidate Cardiac AmyLoidosis

Sponsor: Sharmila Dorbala

View on ClinicalTrials.gov

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.

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

200

Start Date

2025-01-14

Completion Date

2026-02-13

Last Updated

2025-12-19

Healthy Volunteers

No

Interventions

DRUG

I-124 evuzamitide

I-124 evuzamitide, single dose imaging agent, 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