NCT06907849

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

PET/CT Imaging Of Subjects With Lumbar Spinal Stenosis Or Carpal Tunnel Syndrome Using Amyloid-Reactive Peptide 124I-Evuzamitide

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Tennessee Graduate School of Medicine · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2027-03-01
• Completion: 2027-05-01
• First posted: 2025-04-02
• Last updated: 2025-05-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study