Evuzamitide PET Scans to Find Cardiac Amyloidosis When Standard Heart Scans Are Unclear
Tests evuzamitide PET-CT imaging for cardiac amyloidosis in people with unclear standard scans.
Plain-language title generated from the registry record
Registry title: PET Imaging Study Using Evuzamitide to Detect Cardiac Amyloidosis in Patients With Inconclusive Nuclear Scans and Elevated TAD1 Levels
Key facts
- Where
- Boston, Dallas, and New York, United StatesSee the 3 sites
Where in United States
- One Boston Medical Center PlaceBoston, United StatesNo longer taking part
- Bill and Rita Clements Advanced Medical Imaging CenterDallas, United StatesNo longer taking part
- Columbia University Irving Medical CenterNew York, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Lorena Saelices
- Trial code
- NCT07538518
- Record updated
- 22 October 2026
- Original description
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:Read full original descriptionShow less
TAD1 Risk Assessment for Cardiac Amyloidosis With Evuzamitide (TRACE)
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.
Inclusion: 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: Continuous intravenous inotropic therapy; Disabling dementia or other mental or behavioral disease; Chronic kidney disease requiring hemodialysis or peritoneal dialysis; Primary amyloidosis (AL) or secondary amyloidosis (AA); Ventricular assist device; Enrollment in a clinical trial not approved for co-enrollment; Inability or unwillingness to comply with the study requirements; Patients taking heparin, or heparin derivatives (e.g. low molecular weight heparins) for anticoagulation; Other reason that would make the subject inappropriate for entry into this study; Pregnancy or current lactational feeding of infants.