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

Part of paid clinical trials in Knoxville, Tennessee.

Sponsor
University of Tennessee Graduate School of Medicine
Study ID
NCT06907849
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Cardiac Amyloidosis
  • Carpal Tunnel Syndrome (CTS)
  • Lumbar Spinal Stenosis

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 124I-evuzamitide — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 31, 2025
Status verified
May 2025
Primary completion
Mar 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

Detection of cardiac amyloidosis using 124I-evuzamitide PET/CT imaging [ Time Frame: From enrollment to the end of study is 8 days. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Tennessee Graduate School of MedicineKnoxvilleTennessee37920-

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University of Tennessee Graduate School of Medicine· Knoxville, TN

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