Status:
RECRUITING
Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Fibromyalgia
Chronic Fatigue Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study will use brain Positron Emission Tomography/ Magnetic Resonance Imaging (PET/MRI) and an investigational radioactive drug called \[Zr-89\]oxine to track the location of white blood cells (a...
Eligibility Criteria
Inclusion
- 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
- Contraindication to MRI
- Pregnancy
- Lactation
- Individuals who are unable to participate in the imaging portion due to severity of their medical condition
- Chronic infectious disease (e.g. HIV, HCV)
- Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
- Diagnosis of cancer, including leukemia
- Blood or blood clotting disorder
- Except for individuals with MS, a diagnosis of autoimmune disease is exclusionary
- 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
- Currently enrolled in a clinical trial utilizing experimental therapies
- Contraindication to gadolinium based contrast agents
Key Trial Info
Start Date :
October 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03807973
Start Date
October 5 2021
End Date
October 1 2028
Last Update
December 11 2025
Active Locations (1)
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1
UAB
Birmingham, Alabama, United States, 35294