Tracking immune cell movement in the brain for inflammatory disorders
Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.
This study is testing a new way to see how immune cells move in the brain to help understand and improve treatments for conditions like fibromyalgia, chronic fatigue syndrome, and multiple sclerosis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT03807973 on ClinicalTrials.gov |
What this trial studies
This study aims to utilize brain Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) alongside an investigational radioactive drug, [Zr-89]oxine, to monitor the infiltration of white blood cells into the central nervous system. By visualizing these labeled leukocytes, researchers hope to gain insights into neuroinflammation associated with conditions such as fibromyalgia, chronic fatigue syndrome, and multiple sclerosis. The ultimate goal is to enhance diagnostic and treatment strategies for these inflammatory disorders.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 to 65 with a clinical diagnosis of multiple sclerosis, fibromyalgia, chronic fatigue syndrome, or healthy volunteers.
Not a fit: Patients with contraindications to MRI, pregnancy, or certain chronic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic approaches for patients suffering from neuroinflammatory conditions.
How similar studies have performed: While the approach of tracking immune cell infiltration is innovative, similar studies have shown promise in understanding neuroinflammation, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1.18 to 65 years of age 2.Healthy volunteer OR * Clinical diagnosis of Multiple Sclerosis (MS) OR * Meets 2016 American College of Rheumatology (ACR) case definition criteria for fibromyalgia OR * Meets 1994 Fukuda case definition criteria for Chronic Fatigue Syndrome Exclusion Criteria: 1. Contraindication to MRI 2. Pregnancy 3. Lactation 4. Individuals who are unable to participate in the imaging portion due to severity of their medical condition 5. Chronic infectious disease (e.g. HIV, HCV) 6. Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation 7. Diagnosis of cancer, including leukemia 8. Blood or blood clotting disorder 9. Except for individuals with MS, a diagnosis of autoimmune disease is exclusionary 10. Positive urine pregnancy test day of procedure or a serum pregnancy test within 48 hours prior to the administration of Zirconium-89 Oxinate-4-labeled leukocytes 11. Currently enrolled in a clinical trial utilizing experimental therapies 12. Contraindication to gadolinium based contrast agents
Where this trial is running
Birmingham, Alabama
- UAB — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Jonathan McConathy, MD,PhD — University of Alabama at Birmingham
- Study coordinator: Jonathan McConathy, MD, PhD
- Email: jmcconathy@uabmc.edu
- Phone: 205-996-7115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.