Lorena Saelices
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.
This is a prospective, multicenter observational study designed to evaluate the ability of 124I-evuzamitide PET-CT imaging to resolve the diagnosis of transthyretin cardiac amyloidosis (ATTR-CA) in subjects with discordant findings between nuclear scintigraphy and Transthyretin Amyloid Detector 1 (TAD1) levels. Up to 25 participants will be enrolled across three sites in the United States, including the University of Texas Southwestern Medical Center, Columbia University Irving Medical Center, and Boston Medical Center. Participants will be selected from clinical registries and prior screenin…
Inclusion Criteria: 1. Diagnosed as having heart failure or TTR variant allele carriers without symptoms of heart failure. 2. Non-diagnostic nuclear scintigraphy for ATTR-CA (Perugini Grade 0 or 1). 3. Elevated levels of Transthyretin Amyloid Detector-1 (TAD1). 4. No evidence of monoclonal proteins by assessment of serum kappa and lambda free light chain ratio and immunofixation of serum and urine. 5. Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements. 6. Able to understand and sign the inf…
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.
Arctuva estimate
Verify or correct the compensation shown for this listing.