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

Phase 2

• Conditions: Lumbar Spinal Stenosis; Carpal Tunnel Syndrome (CTS); Cardiac Amyloidosis
• Interventions: Drug: 124I-evuzamitide

• Registration Number: NCT06907849
• Lead Sponsor: University of Tennessee Graduate School of Medicine

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.

Study Timeline

• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-03-26
• Study First Posted: 2025-04-02
• Status Verified: 2025-05
• Study Start: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-18
• Primary Completion: 2027-03
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biodistribution	124I-evuzamitide	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.

Primary Outcome Measures

Name	Time	Method
Detection of cardiac amyloidosis using 124I-evuzamitide PET/CT imaging	From enrollment to the end of study is 8 days.	Cardiac PET/CT images will be classified as either positive or negative for 124I-evuzamitide uptake based on visual interpretation.

Secondary Outcome Measures

Name	Time	Method
Measure uptake of 124I-evuzamitide radioactivity in the heart and compare to biomarkers	From enrollment to the end of study is 8 days.	Measure cardiac 124I-evuzamitide uptake and compare to contemporaneous transthoracic echocardiographic parameters, serum NT-proBNP, and high sensitivity troponin T levels
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.	Measure cardiac 124I-evuzamitide uptake and compare to the reported amyloid load, based on Congo red staining, in connective tissue (obtained from LSS or CTS surgery)
Detection of extracardiac amyloid using 124I-evuzamitide PET/CT imaging	From enrollment to the end of study is 8 days.	Visual examination of extracardiac 124I-evuzamitide uptake in the PET/CT images

Trial Locations

Locations (1)

University of Tennessee Graduate School of Medicine; 🇺🇸 Knoxville, Tennessee, United States