124I-Evuzamitide for Spinal Stenosis

Overseen By Emily B. Martin, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Tennessee Graduate School of Medicine

Must not be taking: Heparin

Disqualifiers: Dialysis, Systemic amyloidosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 8 days

40 Participants Needed

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. ^{1 2 3 4 5}

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

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.

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

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

Group I: Biodistribution Experimental Treatment 1 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.

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

1. Germany pubmed.ncbi.nlm.nih.gov

An open study of pamidronate in the treatment of refractory degenerative lumbar spinal stenosis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Intrathecal administration of dizocilpine maleate (MK-801) attenuates ischemic damage in the rabbit spinal cord. [2013]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Specific binding sites for 125I-endothelin-1 in the porcine and human spinal cord. [2019]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical Efficacy of Neurotropin for Lumbar Spinal Stenosis with Low Back Pain. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Zonisamide ameliorates progression of cervical spondylotic myelopathy in a rat model. [2021]