University of Tennessee Graduate School of Medicine
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.
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.
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 m…
124I-evuzamitide is an iodine-124 (124I) labeled 45 L-amino acid peptide (also known as p5+14) suitable for single dose PET/CT imaging. The peptide binds many forms of amyloid through multivalent electrostatic interactions with the amyloid fibril and with the ubiquitous amyloid-associated hypersulfated heparan sulfate proteoglycans.
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