Multiple Sclerosis Clinical Trial

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

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 (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 role of neuroinflammation in fibromyalgia, chronic fatigue syndrome, and multiple sclerosis, the investigator hopes to be able to better diagnose and treat patients in the future.

View Eligibility Criteria

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:

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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT03807973

Recruitment Status:

Recruiting

Sponsor:

University of Alabama at Birmingham

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There is 1 Location for this study

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UAB
Birmingham Alabama, 35294, United States More Info
Evan Hudson, BS
Contact
205-934-6499
[email protected]
Jonathan McConathy, MD,PhD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT03807973

Recruitment Status:

Recruiting

Sponsor:


University of Alabama at Birmingham

How clear is this clinincal trial information?

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