124I-Evuzamitide for Spinal Stenosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new imaging method using 124I-evuzamitide, a radioactive tracer. The goal is to determine if it can detect amyloid, a protein buildup, in the heart and other areas for individuals with a history of spinal stenosis or carpal tunnel syndrome. The trial may suit those who have undergone surgery for these conditions and have been diagnosed with amyloid in their tissue. Participants will receive an injection and undergo specific imaging tests to track the tracer's distribution in their bodies. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
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).
Is there any evidence suggesting that 124I-evuzamitide is likely to be safe for humans?
Research shows that 124I-evuzamitide helps locate amyloid deposits in the body through imaging. Previous studies found this imaging agent generally safe for patients, with no major safety issues reported. Minor side effects might occur, but serious problems are rare. Researchers continue to monitor its safety as the treatment undergoes testing. This trial is in Phase 2, indicating some evidence of safety, but further testing is needed to confirm its safety for a larger population.12345
Why are researchers excited about this study treatment for spinal stenosis?
Most treatments for spinal stenosis focus on pain relief and physical therapy, often involving medications like NSAIDs, opioids, or corticosteroid injections. But 124I-evuzamitide offers a unique approach by using a radiolabeled peptide to potentially pinpoint and address the condition more precisely. Researchers are excited because this treatment combines diagnostic imaging with therapy, allowing for a detailed view of how the drug distributes through the body, which could lead to more targeted and effective interventions. This dual function of treatment and imaging sets it apart from traditional options, offering a glimpse into a personalized approach to managing spinal stenosis.
What evidence suggests that 124I-evuzamitide might be an effective treatment for spinal stenosis?
Research has shown that 124I-evuzamitide effectively detects amyloid buildup in the heart. Studies have found that this substance attaches to amyloid deposits, unusual protein clumps linked to various health issues. This attachment helps identify heart conditions related to amyloid by distinguishing affected patients from healthy individuals. The tracer's accuracy in connecting with cardiac amyloid makes it a promising tool for spotting heart problems related to amyloid. While most research focuses on cardiac applications, this trial will explore its potential in detecting other conditions, such as lumbar spinal stenosis.16789
Who Is on the Research Team?
Emily B. Martin, PhD
Principal Investigator
University of Tennessee Graduate School of Medicine
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are administered 124I-evuzamitide and undergo PET/CT imaging to detect cardiac and extracardiac amyloid
Follow-up
Participants are monitored for safety and effectiveness after imaging
What Are the Treatments Tested in This Trial?
Interventions
- 124I-evuzamitide
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Tennessee Graduate School of Medicine
Lead Sponsor
Attralus, Inc.
Industry Sponsor