PET/CT Imaging Of Subjects With Lumbar Spinal Stenosis Or Carpal Tunnel Syndrome Using Amyloid-Reactive Peptide 124I-Evuzamitide
Trial Snapshot
- Phase
- Phase 2
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Detection of cardiac amyloidosis using 124I-evuzamitide PET/CT imaging
Study Overview
Brief 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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Biodistribution
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.
Intervention: 124I-evuzamitide (Drug)
Outcomes
Primary Outcomes
Detection of cardiac amyloidosis using 124I-evuzamitide PET/CT imaging
Time Frame: From enrollment to the end of study is 8 days.
Cardiac PET/CT images will be classified as either positive or negative for 124I-evuzamitide uptake based on visual interpretation.
Secondary Outcomes
- Measure uptake of 124I-evuzamitide radioactivity in the heart and compare to biomarkers(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(From enrollment to the end of study is 8 days.)
- Detection of extracardiac amyloid using 124I-evuzamitide PET/CT imaging(From enrollment to the end of study is 8 days.)