A Phase 2 interventional study of 124I-evuzamitide in Lumbar Spinal Stenosis, Carpal Tunnel Syndrome (CTS) and Cardiac Amyloidosis, sponsored by University of Tennessee Graduate School of Medicine. Enrolling by invitation at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by University of Tennessee Graduate School of Medicine · Phase 2, Interventional, and Diagnostic
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.
458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 281 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →University of Tennessee Graduate School of Medicine is the lead sponsor of 27 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be administered \~1 mCi of 124I-evuzamitide (up to 1 mg of peptide) by IV push at a proposed rate of \~1 mL per 5 seconds. Three hours after injection, a PET/CT image acquisition from shoulder to thigh as well as a 10 min static PET image of the heart will be performed.
Drug: 124I-evuzamitide
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.
Also known as: AT-01
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.
Plan to share: No
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University of Tennessee Graduate School of Medicine