Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Jan 14, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how white blood cells, which are important for fighting infections and inflammation, move into the brain in people with certain health conditions like fibromyalgia, chronic fatigue syndrome, and multiple sclerosis. Researchers will use a special imaging technique called PET/MRI along with a radioactive drug that helps track these cells. By understanding how these cells affect the brain, the researchers hope to improve diagnosis and treatment for these conditions in the future.

To participate, you need to be between 18 and 65 years old and either a healthy volunteer or someone diagnosed with one of the conditions mentioned. However, there are some reasons you might not be able to join, such as if you are pregnant, have certain serious health issues, or are currently part of another clinical trial. If you join, you can expect to undergo imaging tests that will help researchers see how your immune cells interact with your brain. This study aims to provide valuable insights that could lead to better care for patients dealing with these challenging conditions.

Gender

ALL

Eligibility 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