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

April 13, 2026 updated by: Lorena Saelices

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Shumaila Afrin, Ph.D.
  • Phone Number: 214-677-5721

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • One Boston Medical Center Place
        • Contact:
        • Contact:
        • Principal Investigator:
          • Frederick Ruberg, M.D.
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center
        • Contact:
        • Contact:
          • Stephen Helmke
        • Principal Investigator:
          • Mathew Maurer, M.D.
    • Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  1. Diagnosed as having heart failure or TTR variant allele carriers without symptoms of heart failure.
  2. Non-diagnostic nuclear scintigraphy for ATTR-CA (Perugini Grade 0 or 1).
  3. Elevated levels of Transthyretin Amyloid Detector-1 (TAD1).
  4. No evidence of monoclonal proteins by assessment of serum kappa and lambda free light chain ratio and immunofixation of serum and urine.
  5. 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.
  6. Able to understand and sign the informed consent document after the nature of the study has been fully explained.

Exclusion Criteria:

  1. Primary amyloidosis (AL) or secondary amyloidosis (AA).
  2. Ventricular assist device.
  3. Disabling dementia or other mental or behavioral disease.
  4. Enrollment in a clinical trial not approved for co-enrollment.
  5. Continuous intravenous inotropic therapy.
  6. Inability or unwillingness to comply with the study requirements.
  7. Chronic kidney disease requiring hemodialysis or peritoneal dialysis.
  8. Patients taking heparin, or heparin derivatives (e.g. low molecular weight heparins) for anticoagulation.
  9. Other reason that would make the subject inappropriate for entry into this study.
  10. Pregnancy or current lactational feeding of infants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Evuzamitide
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.
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.
Drug: Evuzamitide
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At approximately 4 hours (±1 hour) post-injection on Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lorena Saelices

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 15, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU20252574
  • 1R01HL177670-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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