ClinicalTrials.gov record NCT07538518

PET Imaging Study Using Evuzamitide to Detect Cardiac Amyloidosis in Patients With Inconclusive Nuclear Scans and Elevated TAD1 Levels

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 23, 2026

TAD1 Risk Assessment for Cardiac Amyloidosis With Evuzamitide (TRACE)

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational study looks at PET-CT imaging with 124I-evuzamitide in people whose standard nuclear scans are non-diagnostic but who have elevated TAD1 blood levels. Participants receive a single IV dose of 124I-evuzamitide, a PET-CT scan about 4 hours later, and potassium iodide before and after imaging. They are followed for about 28 days for safety and additional clinical information.

What it is studying. The study is testing whether a single PET-CT scan after intravenous 124I-evuzamitide shows myocardial uptake that helps resolve diagnostic uncertainty for transthyretin (ATTR) cardiac amyloidosis in people with non-diagnostic nuclear scintigraphy and elevated TAD1. It also records how images are read and tracks safety over roughly 28 days.

What the researchers hope to learn. To determine how often 124I-evuzamitide PET-CT shows myocardial uptake in people with non-diagnostic nuclear scans and elevated TAD1, to describe image interpretation methods, and to collect safety information over about 28 days.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Evuzamitide

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.
  • Continuous intravenous inotropic therapy.
  • Inability or unwillingness to comply with the study requirements.
  • 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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will receive a single intravenous injection of 124I-evuzamitide (about 1 mCi) and undergo a PET-CT scan approximately 4 hours after the injection. Potassium iodide will be given before and after imaging to reduce thyroid exposure. Study staff will monitor safety with physical exams, vital signs, and adverse event checks, and PET-CT images will be evaluated by trained physicians with discrepancies resolved by consensus review. There will be follow-up about 28 days after imaging to collect additional safety and clinical information.

How the study is structured. This is a prospective observational cohort study enrolling up to 25 participants in two cohorts (people with heart failure and asymptomatic TTR variant carriers) who have non-diagnostic nuclear scintigraphy and elevated TAD1. Each participant receives one intravenous injection of approximately 1 mCi 124I-evuzamitide, PET-CT imaging about 4 ± 1 hours later, and potassium iodide before and after imaging to reduce thyroid exposure. Images are evaluated qualitatively and quantitatively by trained physicians with consensus review for discrepancies. Safety is monitored with adverse event checks, vital signs, and physical exams, with a follow-up visit about 28 days after imaging.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on ATTRv amyloidosis

This trial is also listed on this site under wild-type ATTR amyloidosis.

Clinical trials106 trials listed for ATTRv amyloidosisEvery trial the registry lists for ATTRv amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in ATTRv amyloidosis researchLatest monthly update: September 2026. Includes: Gene-silencing drugs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Oct 1, 2026 (estimated)
Primary completion
Mar 15, 2028 (estimated)
Study completion
Apr 1, 2028 (estimated)
Target enrollment
25 participants (estimated)
Last updated on registry
Sep 3, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Lorena Saelices
Collaborators
  • National Heart, Lung, and Blood Institute (NHLBI)

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (3)

Terms used on this page · explanations by MedicalUpdates.ai

PET
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
CT
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
eligibility criteria
The rules the study team uses to decide who may take part. They are usually split into inclusion criteria and exclusion criteria.
free light chain
Small pieces of antibody protein made by plasma cells and measured in a blood test. In some conditions, such as AL amyloidosis, abnormal free light chains are the source of the disease.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
clinical trial
A study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
adverse event
Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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