Clinical Trial Finder

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 60 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06907849
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Tennessee Graduate School of Medicine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Emily B. Martin, PhD
Principal Investigator Affiliation University of Tennessee Graduate School of Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Lumbar Spinal Stenosis, Carpal Tunnel Syndrome (CTS), Cardiac Amyloidosis
Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Knoxville, Tennessee

Status

Address

University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, 37920

Site Contact

Emily B. Martin, PhD

[email protected]

865-305-9533

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