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

PET/CT Imaging Of Subjects With Lumbar Spinal Stenosis Or Carpal Tunnel Syndrome Using Amyloid-Reactive Peptide 124I-Evuzamitide

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lumbar Spinal Stenosis; Cardiac Amyloidosis; Carpal Tunnel Syndrome (CTS)
• Intervention / Treatment: Drug: 124I-evuzamitide

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Graduate School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: AT-01

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of cardiac amyloidosis using 124I-evuzamitide PET/CT imaging	Cardiac PET/CT images will be classified as either positive or negative for 124I-evuzamitide uptake based on visual interpretation.	From enrollment to the end of study is 8 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure uptake of 124I-evuzamitide radioactivity in the heart and compare to biomarkers	Measure cardiac 124I-evuzamitide uptake and compare to contemporaneous transthoracic echocardiographic parameters, serum NT-proBNP, and high sensitivity troponin T levels	From enrollment to the end of study is 8 days.
Measure uptake of 124I-evuzamitide radioactivity in the heart and compare to amyloid load in connective tissue	Measure cardiac 124I-evuzamitide uptake and compare to the reported amyloid load, based on Congo red staining, in connective tissue (obtained from LSS or CTS surgery)	From enrollment to the end of study is 8 days.
Detection of extracardiac amyloid using 124I-evuzamitide PET/CT imaging	Visual examination of extracardiac 124I-evuzamitide uptake in the PET/CT images	From enrollment to the end of study is 8 days.

Collaborators and Investigators

• Sponsor: University of Tennessee Graduate School of Medicine
• Collaborators: Attralus, Inc.
• Investigators: Principal Investigator: Emily B. Martin, PhD, University of Tennessee Graduate School of Medicine

Publications and helpful links

General Publications

• Wall JS, Martin EB, Lands R, Ramchandren R, Stuckey A, Heidel RE, Whittle B, Powell D, Richey T, Williams AD, Foster JS, Guthrie S, Kennel SJ. Cardiac Amyloid Detection by PET/CT Imaging of Iodine (124I) Evuzamitide (124I-p5+14): A Phase 1/2 Study. JACC Cardiovasc Imaging. 2023 Nov;16(11):1433-1448. doi: 10.1016/j.jcmg.2023.08.009.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: PET Imaging; Spinal Stenosis; Amyloidosis; Carpal Tunnel Syndrome; p5+14; iodine-124-evuzamitide
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Anatomical; Neuromuscular Diseases; Metabolic Diseases; Peripheral Nervous System Diseases; Disease; Spinal Diseases; Proteostasis Deficiencies; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Constriction, Pathologic; Spinal Stenosis; Amyloidosis; Carpal Tunnel Syndrome
• Other Study ID Numbers: UTGSM-172768-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No