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

NCT ID: NCT06907849

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2027-05-31

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.

Detailed Description

This is a single center, open label, pilot study using an amyloid-reactive peptide labeled with iodine-124 (124I-evuzamitide) and PET/CT imaging to detect the presence of cardiac and extracardiac amyloid in patients who have undergone surgical intervention for lumbar spinal stenosis (LSS) or carpal tunnel syndrome (CTS) and who have amyloid-positive connective tissue [ligamentum flavum (LF) in LSS patients or tenosynovium in CTS patients] assessed at the time of the corrective surgery.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Biodistribution

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.

Group Type: EXPERIMENTAL

124I-evuzamitide

Intervention Type: 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.

Interventions

124I-evuzamitide

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.

Intervention Type: DRUG

Other Intervention Names

AT-01

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Attralus, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Tennessee Graduate School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily B. Martin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee Graduate School of Medicine

Locations

University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 37940323 (View on PubMed)

Other Identifiers

UTGSM-172768-101

Identifier Type: -

Identifier Source: org_study_id