PET Imaging Study Using Evuzamitide to Detect Cardiac Amyloidosis in Patients With Inconclusive N… (NCT07538518) | Clinical Trial Compass
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PET Imaging Study Using Evuzamitide to Detect Cardiac Amyloidosis in Patients With Inconclusive Nuclear Scans and Elevated TAD1 Levels
United States25 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
SexALL
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Inclusion criteria
✓. Diagnosed as having heart failure or TTR variant allele carriers without symptoms of heart failure.
✓. Non-diagnostic nuclear scintigraphy for ATTR-CA (Perugini Grade 0 or 1).
✓. Elevated levels of Transthyretin Amyloid Detector-1 (TAD1).
✓. No evidence of monoclonal proteins by assessment of serum kappa and lambda free light chain ratio and immunofixation of serum and urine.
✓. 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.
✓. Able to understand and sign the informed consent document after the nature of the study has been fully explained.
Exclusion criteria
✕. Primary amyloidosis (AL) or secondary amyloidosis (AA).
✕. Ventricular assist device.
✕. Disabling dementia or other mental or behavioral disease.
✕. Enrollment in a clinical trial not approved for co-enrollment.
What they're measuring
1
Number of Participants With Myocardial Uptake of Evuzamitide on PET/CT Imaging
Timeframe: At approximately 4 hours (±1 hour) post-injection on Day 1