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Enrolling by invitation NCT06907849

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

Phase II Interventional Lumbar Spinal Stenosis Carpal Tunnel Syndrome (CTS) Cardiac Amyloidosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 124I-evuzamitide.
Who it may be relevant to
Registry conditions: Lumbar Spinal Stenosis, Carpal Tunnel Syndrome (CTS), Cardiac Amyloidosis. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

PET/CT Imaging Of Subjects With Lumbar Spinal Stenosis Or Carpal Tunnel Syndrome Using Amyloid-Reactive Peptide 124I-Evuzamitide

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Detection of cardiac amyloidosis using 124I-evuzamitide PET/CT imaging [Time frame: From enrollment to the end of study is 8 days.]
Secondary outcome measures (3)
  • Measure uptake of 124I-evuzamitide radioactivity in the heart and compare to biomarkers [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 [Time frame: From enrollment to the end of study is 8 days.]
  • Detection of extracardiac amyloid using 124I-evuzamitide PET/CT imaging [Time frame: From enrollment to the end of study is 8 days.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • University of Tennessee Graduate School of Medicine — Knoxville

Publications

  • Wall JS, Martin EB, Lands R, Ramchandren R, Stuckey A, Heidel RE, Whittle B, Powell D, Richey T, Williams AD, Foster JS, Guthrie S, Kennel SJ. Cardiac Amyloid Detection by PET/CT Imaging of Iodine (124I) Evuzamitide (124I-p5+14): A Phase 1/2 Study. JACC Cardiovasc Imaging. 2023 Nov;16(11):1433-1448. doi: 10.1016/j.jcmg.2023.08.009. PMID 37940323

Identifiers

NCT: NCT06907849 · UTGSM-172768-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗