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NOT YET RECRUITING
NCT07538518

PET Imaging Study Using Evuzamitide to Detect Cardiac Amyloidosis in Patients With Inconclusive Nuclear Scans and Elevated TAD1 Levels

Sponsor: Lorena Saelices

View on ClinicalTrials.gov

Summary

The goal of this study is to learn whether PET-CT imaging using evuzamitide can help diagnose transthyretin cardiac amyloidosis (ATTR-CA) in patients whose standard nuclear imaging results are unclear but who have elevated TAD1 levels in their blood. The main question it aims to answer is: Can evuzamitide PET-CT imaging detect signs of cardiac amyloidosis in patients with non-diagnostic nuclear scintigraphy but elevated TAD1 levels? Participants who meet eligibility criteria will receive a single PET-CT scan with evuzamitide and will be followed for approximately 28 days to monitor safety and collect additional clinical information.

Official title: TAD1 Risk Assessment for Cardiac Amyloidosis With Evuzamitide (TRACE)

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

25

Start Date

2026-10-01

Completion Date

2028-04-01

Last Updated

2026-09-03

Healthy Volunteers

No

Interventions

DRUG

Evuzamitide

Eligible participants will receive a single intravenous injection of approximately 1 mCi (±10%) of 124I-evuzamitide (corresponding to \<1.5 mg peptide). PET-CT imaging will be performed approximately 4 ± 1 hours after administration to evaluate myocardial uptake.

Locations (3)

One Boston Medical Center Place

Boston, Massachusetts, United States

Columbia University Irving Medical Center

New York, New York, United States

Bill and Rita Clements Advanced Medical Imaging Center

Dallas, Texas, United States