NCT07538518Not yet recruiting
PET Imaging Study Using Evuzamitide to Detect Cardiac Amyloidosis in Patients With Inconclusive Nuclear Scans and Elevated TAD1 Levels
TAD1 Risk Assessment for Cardiac Amyloidosis With Evuzamitide (TRACE)
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 25 (estimated)
- First submitted
- 13 Apr 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 15 Mar 2028
- Lead sponsor
- Lorena Saelices
- Diseases
- Amyloidosis
- NCT number
- NCT07538518
What you commit to
- Study type: Observational
- Planned participants: 25
- From 1 Oct 2026 to the primary completion date, 15 Mar 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Continuous intravenous inotropic therapy.
Other illness
- Disabling dementia or other mental or behavioral disease.
- Chronic kidney disease requiring hemodialysis or peritoneal dialysis.
Other
- 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.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| One Boston Medical Center Place Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Bill and Rita Clements Advanced Medical Imaging Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.