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

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will use brain PET/MRI and an investigational radioactive drug called [Zr-89]oxine to track the location of white blood cells (also called leukocytes) in the body. PET/MRI will be used to visualize labeled white blood cells and determine if they enter the central nervous system in conditions associated with brain inflammation (also called neuroinflammation). By better understanding the roleneuroinflammation in fibromyalgia, chronic fatigue syndrome, and multiple sclerosis, the investigator hopes to be able to better diagnose and treat patients in the future.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham

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 β-hCG test day of procedure or a serum hCG test within 48 hours prior to the administration of [89Zr]Oxinate-4-labeled leukocytes

11. Currently enrolled in a clinical trial utilizing experimental therapies

12. Contraindication to gadolinium based contrast agents