124I-Evuzamitide for Spinal Stenosis

Overseen by Emily B. Martin, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Tennessee Graduate School of Medicine

No Placebo Group

Prior Safety Data

Trial Summary

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

Treatment Details

Interventions

• 124I-evuzamitide (Amyloid-binding radiotracer)

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+