Status:
ENROLLING_BY_INVITATION
124I-Evuzamitide PET/CT Imaging In Patients With Lumbar Spinal Stenosis and Carpal Tunnel Syndrome
Lead Sponsor:
University of Tennessee Graduate School of Medicine
Collaborating Sponsors:
Attralus, Inc.
Conditions:
Lumbar Spinal Stenosis
Carpal Tunnel Syndrome (CTS)
Eligibility:
All Genders
60+ years
Phase:
PHASE2
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/...
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 amyl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06907849
Start Date
May 1 2025
End Date
May 1 2027
Last Update
May 18 2025
Active Locations (1)
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1
University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, United States, 37920