40 Participants Needed

124I-Evuzamitide for Spinal Stenosis

EB
Overseen ByEmily B. Martin, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Tennessee Graduate School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking heparin or heparin derivatives (blood thinners).

How does the drug 124I-evuzamitide differ from other treatments for spinal stenosis?

The drug 124I-evuzamitide is unique because it involves a radiolabeled component (124I), which may allow for targeted delivery or imaging capabilities, unlike traditional treatments for spinal stenosis that do not typically use radiolabeled compounds.12345

What is the purpose of this trial?

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.

Research Team

EB

Emily B. Martin, PhD

Principal Investigator

University of Tennessee Graduate School of Medicine

Eligibility Criteria

This trial is for patients with a history of lumbar spinal stenosis and/or carpal tunnel syndrome. It aims to detect amyloid deposits in the heart and other areas using a special imaging agent.

Inclusion Criteria

I am 60 years old or older.
Must have given written informed consent and be able to comply with all study requirements
I am not pregnant or breastfeeding.
See 2 more

Exclusion Criteria

Other reason that would make the subject inappropriate for entry into this study
I am on heparin or similar medication for blood thinning.
History of iodine allergy
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are administered 124I-evuzamitide and undergo PET/CT imaging to detect cardiac and extracardiac amyloid

8 days
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

1-2 weeks

Treatment Details

Interventions

  • 124I-evuzamitide
Trial Overview The intervention being studied is an amyloid-binding radiotracer called 124I-evuzamitide, used during PET/CT scans to visualize amyloid presence associated with various syndromes including cardiac conditions.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: BiodistributionExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Tennessee Graduate School of Medicine

Lead Sponsor

Trials
17
Recruited
1,400+

Attralus, Inc.

Industry Sponsor

Trials
8
Recruited
670+

References

An open study of pamidronate in the treatment of refractory degenerative lumbar spinal stenosis. [2021]
Intrathecal administration of dizocilpine maleate (MK-801) attenuates ischemic damage in the rabbit spinal cord. [2013]
Specific binding sites for 125I-endothelin-1 in the porcine and human spinal cord. [2019]
Clinical Efficacy of Neurotropin for Lumbar Spinal Stenosis with Low Back Pain. [2023]
Zonisamide ameliorates progression of cervical spondylotic myelopathy in a rat model. [2021]
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