Amyloidogenic Transthyretin (ATTR) AmyloidosisTRACENCT07538518
PET Imaging Study Using Evuzamitide to Detect Cardiac Amyloidosis in Patients With Inconclusive Nuclear Scans and Elevated TAD1 Levels
An observational study of Amyloidogenic Transthyretin (ATTR) Amyloidosis and Cardiac Amyloidosis, run by Lorena Saelices at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Amyloidogenic Transthyretin (ATTR) Amyloidosis, Cardiac Amyloidosis
- What is being tested?
- Evuzamitide
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2026to 1 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants will be drawn from clinical practice registries and epidemiological ATTR-CA screening projects at UT Southwestern, Columbia University Irving Medical Center, and Boston Medical Center
Who may be able to join
- 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.
Who cannot join
- 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.
- Continuous intravenous inotropic therapy.
- Inability or unwillingness to comply with the study requirements.
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- Chronic kidney disease requiring hemodialysis or peritoneal dialysis.
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Shumaila Afrin, Ph.D. contact
United States3 sites
One Boston Medical Center Place
Boston, Massachusetts, 02118
Frederick Ruberg, M.D, 617-638-8733, Frederick.Ruberg@bmc.org
Denise Fine, Denise.Fine@bmc.org
Bill and Rita Clements Advanced Medical Imaging Center
Dallas, Texas, 75235-8823
Lorena Saelices, 2146488846, Lorena.SaelicesGomez@UTSouthwestern.edu
Columbia University Irving Medical Center
New York, New York, 10032
Mathew Maurer, M.D, 212-932-4537, msm10@cumc.columbia.edu
Stephen Helmke
About this study
Official title: 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.
Read the detailed description
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 screening studies and must have non-diagnostic nuclear scintigraphy for ATTR-CA and elevated TAD1 levels.
Eligible participants will receive a single intravenous administration of approximately 1 mCi of 124I-evuzamitide, followed by PET-CT imaging performed approximately 4 hours post-injection. Potassium iodide will be administered before and after imaging to reduce thyroid exposure.
PET-CT images will be evaluated qualitatively and quantitatively for myocardial uptake of the tracer. Image interpretation will be performed by trained physicians, and discrepancies will be resolved by consensus review.
Safety will be assessed through adverse event monitoring, vital signs, and physical examinations, with follow-up conducted approximately 28 days after imaging.
- Being tested
- Evuzamitide
- Keywords
- transthyretin, cardiac amyloidosis, TAD1, nuclear scintigraphy, Evuzamitide
- Medical subject headings
- Amyloidosis, Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvuzamitideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with heart failure, who have non-diagnostic nuclear scintigraphy and elevated TAD1 | This cohort includes subjects with heart failure who have non-diagnostic nuclear scintigraphy (Perugini Grade 0 or 1) and elevated TAD1 levels. Receives: Drug: Evuzamitide | |
| Asymptomatic TTR Variant Carriers with non-diagnostic scintigraphy and elevated TAD1 | This cohort includes non-symptomatic carriers of transthyretin (TTR) variants who have non-diagnostic nuclear scintigraphy (Perugini Grade 0 or 1) and elevated TAD1 levels. Receives: Drug: Evuzamitide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Myocardial Uptake of Evuzamitide on PET/CT Imaging
The primary outcome of this study is the number (and percent) of subjects with myocardial uptake of evuzamitide on PET/CT imaging.
Measured: At approximately 4 hours (±1 hour) post-injection on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Oct 2026 (estimated)
- Primary completion15 Mar 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyloidogenic Transthyretin (ATTR) AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lorena Saelices
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Lorena Saelices, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538518
- Sponsor's protocol ID
- STU20252574
- Other IDs
- 1R01HL177670-01
- Acronym
- TRACE
- Status last verified
- Oct 2026
- First submitted
- 13 Apr 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAD1 Risk Assessment for Cardiac Amyloidosis With Evuzamitide (TRACE)
- ClinicalTrials.gov ID
- NCT07538518
- Acronym / sponsor ID
- TRACE / STU20252574
- Keywords
- transthyretin, cardiac amyloidosis, TAD1, nuclear scintigraphy, Evuzamitide
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Lorena SaelicesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 15 Mar 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 screening studies and must have non-diagnostic nuclear scintigraphy for ATTR-CA and elevated TAD1 levels.
Eligible participants will receive a single intravenous administration of approximately 1 mCi of 124I-evuzamitide, followed by PET-CT imaging performed approximately 4 hours post-injection. Potassium iodide will be administered before and after imaging to reduce thyroid exposure.
PET-CT images will be evaluated qualitatively and quantitatively for myocardial uptake of the tracer. Image interpretation will be performed by trained physicians, and discrepancies will be resolved by consensus review.
Safety will be assessed through adverse event monitoring, vital signs, and physical examinations, with follow-up conducted approximately 28 days after imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with heart failure, who have non-diagnostic nuclear scintigraphy and elevated TAD1 | – | Drug: EvuzamitideThis cohort includes subjects with heart failure who have non-diagnostic nuclear scintigraphy (Perugini Grade 0 or 1) and elevated TAD1 levels. |
| Asymptomatic TTR Variant Carriers with non-diagnostic scintigraphy and elevated TAD1 | – | Drug: EvuzamitideThis cohort includes non-symptomatic carriers of transthyretin (TTR) variants who have non-diagnostic nuclear scintigraphy (Perugini Grade 0 or 1) and elevated TAD1 levels. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be drawn from clinical practice registries and epidemiological ATTR-CA screening projects at UT Southwestern, Columbia University Irving Medical Center, and Boston Medical Center
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
- Continuous intravenous inotropic therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvuzamitideEligible 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. | Drug | Asymptomatic TTR Variant Carriers with non-diagnostic scintigraphy and elevated TAD1, Participants with heart failure, who have non-diagnostic nuclear scintigraphy and elevated TAD1 |
Primary outcome
Number of Participants With Myocardial Uptake of Evuzamitide on PET/CT Imaging
Time frame: At approximately 4 hours (±1 hour) post-injection on Day 1
The primary outcome of this study is the number (and percent) of subjects with myocardial uptake of evuzamitide on PET/CT imaging.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Amyloidogenic Transthyretin (ATTR) Amyloidosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shumaila Afrin, Ph.D. contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyloidogenic Transthyretin (ATTR) Amyloidosis and Cardiac Amyloidosis, run by Lorena Saelices at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorena Saelices Gomez, Ph.D. (323-847-9327, Lorena.SaelicesGomez@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Myocardial Uptake of Evuzamitide on PET/CT Imaging (time frame: At approximately 4 hours (±1 hour) post-injection on Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.