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

Launched by UNIVERSITY OF TENNESSEE GRADUATE SCHOOL OF MEDICINE · Mar 26, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring the use of a special imaging technique, called PET/CT, to see if it can help find amyloid deposits in the heart and other areas of the body in patients with lumbar spinal stenosis or carpal tunnel syndrome. Amyloid is a type of protein that can build up and cause health problems. To participate, individuals need to be at least 60 years old and have had a specific type of tissue sample taken during surgery that shows a certain level of amyloid. They should also have a history of other orthopedic issues, like carpal tunnel syndrome or lumbar spinal stenosis.

If you qualify for this study, you will undergo a PET/CT scan that takes about 40 minutes, where you will need to lie still. The trial is not yet recruiting participants, but it’s important to know that certain conditions, like being on dialysis or having a confirmed diagnosis of systemic amyloidosis, would exclude someone from participating. This research could help improve understanding of amyloid-related conditions and lead to better treatment options in the future.

Gender

ALL

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.