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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
40
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.
University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, United States
Detection of cardiac amyloidosis using 124I-evuzamitide PET/CT imaging
Cardiac PET/CT images will be classified as either positive or negative for 124I-evuzamitide uptake based on visual interpretation.
Time frame: From enrollment to the end of study is 8 days.
Measure uptake of 124I-evuzamitide radioactivity in the heart and compare to biomarkers
Measure cardiac 124I-evuzamitide uptake and compare to contemporaneous transthoracic echocardiographic parameters, serum NT-proBNP, and high sensitivity troponin T levels
Time frame: From enrollment to the end of study is 8 days.
Measure uptake of 124I-evuzamitide radioactivity in the heart and compare to amyloid load in connective tissue
Measure cardiac 124I-evuzamitide uptake and compare to the reported amyloid load, based on Congo red staining, in connective tissue (obtained from LSS or CTS surgery)
Time frame: From enrollment to the end of study is 8 days.
Detection of extracardiac amyloid using 124I-evuzamitide PET/CT imaging
Visual examination of extracardiac 124I-evuzamitide uptake in the PET/CT images
Time frame: From enrollment to the end of study is 8 days.
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