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