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

NCT07538518 | Not Yet Recruiting FDA Drug

• 2 other identifiers: STU202525741R01HL177670-01
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Amyloidogenic Transthyretin (ATTR) Amyloidosis; Cardiac Amyloidosis

Keywords

transthyretin; cardiac amyloidosis; TAD1; nuclear scintigraphy; Evuzamitide

Outcome Measures

Primary Outcomes (1)

• 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.

  At approximately 4 hours (±1 hour) post-injection on Day 1

Study Arms (2)

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

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

Interventions

Evuzamitide DRUG

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; Participants with heart failure, who have non-diagnostic nuclear scintigraphy and elevated TAD1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lorena Saelices: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

One Boston Medical Center Place

Boston, Massachusetts, 02118, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Bill and Rita Clements Advanced Medical Imaging Center

Dallas, Texas, 75235-8823, United States

Location

MeSH Terms

Conditions

Amyloidosis; Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors

Central Study Contacts

Lorena Saelices Gomez, Ph.D.

CONTACT

323-847-9327; Lorena.SaelicesGomez@UTSouthwestern.edu

Shumaila Afrin, Ph.D.

CONTACT

214-677-5721

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (3)