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Enrolling By Invitation
NCT06907849
124I-Evuzamitide PET/CT Imaging In Patients With Lumbar Spinal Stenosis and Carpal Tunnel Syndrome
Conditions: Lumbar Spinal Stenosis, Carpal Tunnel Syndrome (CTS), Cardiac Amyloidosis
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 40
Sponsor: University of Tennessee Graduate School of Medicine
Location: University of Tennessee Graduate School of Medicine Knoxville Tennessee
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.
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.
Source: ClinicalTrials.gov (NCT06907849). StuddyBuddy aggregates publicly available trial information.