NCT06788535

Research With I-124 EVuzamitide to Elucidate 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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Sharmila Dorbala · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cardiac Amyloidosis

Interventions

Type	Name	Description
DRUG	I-124 evuzamitide	I-124 evuzamitide, single dose imaging agent, administered intravenously.

Timeline

• Start date: 2025-01-14
• Primary completion: 2026-02-13
• Completion: 2026-02-13
• First posted: 2025-01-23
• Last updated: 2025-12-19

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study