124I-Evuzamitide PET/CT Imaging In Patients With Lumbar Spinal Stenosis and Carpal Tunnel Syndrome

NCT06907849 | Enrolling By Invitation Phase 2 FDA Drug

• 1 other identifier: UTGSM-172768-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial will use the amyloid-binding radiotracer, 124I-evuzamitide, to potentially detect amyloid, in the heart and elsewhere, in patients who have a history of lumbar spinal stenosis and/or carpal tunnel syndrome.

Conditions

Lumbar Spinal Stenosis; Carpal Tunnel Syndrome (CTS); Cardiac Amyloidosis

Keywords

iodine-124-evuzamitide; PET Imaging; Amyloidosis; Spinal Stenosis; Carpal Tunnel Syndrome; p5+14

Outcome Measures

Primary Outcomes (1)

• Detection of cardiac amyloidosis using 124I-evuzamitide PET/CT imaging

  Cardiac PET/CT images will be classified as either positive or negative for 124I-evuzamitide uptake based on visual interpretation.

  From enrollment to the end of study is 8 days.

Secondary Outcomes (3)

• Measure uptake of 124I-evuzamitide radioactivity in the heart and compare to biomarkers

  From enrollment to the end of study is 8 days.

• Measure uptake of 124I-evuzamitide radioactivity in the heart and compare to amyloid load in connective tissue

  From enrollment to the end of study is 8 days.

• Detection of extracardiac amyloid using 124I-evuzamitide PET/CT imaging

  From enrollment to the end of study is 8 days.

Study Arms (1)

Biodistribution

EXPERIMENTAL

Participants will be administered \~1 mCi of 124I-evuzamitide (up to 1 mg of peptide) by IV push at a proposed rate of \~1 mL per 5 seconds. Three hours after injection, a PET/CT image acquisition from shoulder to thigh as well as a 10 min static PET image of the heart will be performed.

Drug: 124I-evuzamitide

Interventions

124I-evuzamitide DRUG

124I-evuzamitide is an iodine-124 (124I) labeled 45 L-amino acid peptide (also known as p5+14) suitable for single dose PET/CT imaging. The peptide binds many forms of amyloid through multivalent electrostatic interactions with the amyloid fibril and with the ubiquitous amyloid-associated hypersulfated heparan sulfate proteoglycans.

Also known as: AT-01

Biodistribution

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be ≥ 60 years of age.
• 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.
• Must have a Congo red positive ligamentum flavum or tenosynovial specimen analysis after laminectomy or carpal tunnel release surgery that is visually categorized as either "extensive" amyloid load or "mild/moderate" amyloid load by an experienced reviewer.
• Those with mild/moderate amyloid load in the connective tissue who also have a history of at least one other orthopedic clinical manifestation, including, but not limited to, carpal tunnel syndrome, lumbar spinal stenosis, trigger finger, biceps tendon rupture, and shoulder/hip/knee arthroplasty.
• Females must be non-pregnant and non-lactating.

You may not qualify if:

• Subjects on dialysis.
• Subjects with a confirmed diagnosis of systemic amyloidosis, other than musculoskeletal tissue.
• Inability or unwillingness to comply with the study requirements.
• Subjects taking heparin, or heparin derivatives (e.g. low molecular weight heparins) for anticoagulation.
• Inability to lie still for \~40 minutes on the PET/CT scanner.
• History of iodine (potassium iodide) allergy.
• Other reason that would make the subject inappropriate for entry into this study.

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead
• Attralus, Inc.: collaborator

Study Sites (1)

University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, 37920, United States

Location

Related Publications (1)

• Wall JS, Martin EB, Lands R, Ramchandren R, Stuckey A, Heidel RE, Whittle B, Powell D, Richey T, Williams AD, Foster JS, Guthrie S, Kennel SJ. Cardiac Amyloid Detection by PET/CT Imaging of Iodine (124I) Evuzamitide (124I-p5+14): A Phase 1/2 Study. JACC Cardiovasc Imaging. 2023 Nov;16(11):1433-1448. doi: 10.1016/j.jcmg.2023.08.009.

  PMID: 37940323 BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis; Carpal Tunnel Syndrome; Amyloid Neuropathies, Familial; Amyloidosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Amyloid Neuropathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Proteostasis Deficiencies

Study Officials

• Emily B. Martin, PhD

  University of Tennessee Graduate School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)