Clinical trial NCT06907849: 124I-Evuzamitide PET/CT Imaging In Patients With Lumbar Spinal Stenosis and Carpal Tunnel Syndrome
Official title: PET/CT Imaging Of Subjects With Lumbar Spinal Stenosis Or Carpal Tunnel Syndrome Using Amyloid-Reactive Peptide 124I-Evuzamitide
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Lumbar Spinal Stenosis
Carpal Tunnel Syndrome (CTS)
Cardiac Amyloidosis
Keywords: iodine-124-evuzamitide
PET Imaging
Amyloidosis
Spinal Stenosis
Carpal Tunnel Syndrome
p5+14
Lead sponsor: University of Tennessee Graduate School of Medicine
Sponsor class: OTHER
Collaborators: name: Attralus, Inc.
First posted: 2025-04-02
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Detection of cardiac amyloidosis using 124I-evuzamitide PET/CT imaging
timeFrame: From enrollment to the end of study is 8 days.
Secondary outcomes:
measure: Measure uptake of 124I-evuzamitide radioactivity in the heart and compare to biomarkers
timeFrame: From enrollment to the end of study is 8 days.
measure: Measure uptake of 124I-evuzamitide radioactivity in the heart and compare to amyloid load in connective tissue
timeFrame: From enrollment to the end of study is 8 days.
measure: Detection of extracardiac amyloid using 124I-evuzamitide PET/CT imaging
timeFrame: From enrollment to the end of study is 8 days.
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee Graduate School of Medicine
state: Tennessee
Study officials:
affiliation: University of Tennessee Graduate School of Medicine
name: Emily B. Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.