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

The University of Alabama at Birmingham

Status and phase: Enrolling; Phase 1

Conditions: Fibromyalgia; Healthy; Multiple Sclerosis; Chronic Fatigue Syndrome

Treatments: Drug: [Zr-89]Oxine-labeled leukocytes PET/MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT03807973

R18-179

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

Fibromyalgia

Experimental group

Treatment:

Drug: [Zr-89]Oxine-labeled leukocytes PET/MRI

Chronic Fatigue Syndrome

Experimental group

Treatment:

Drug: [Zr-89]Oxine-labeled leukocytes PET/MRI

Multiple Sclerosis

Experimental group

Treatment:

Drug: [Zr-89]Oxine-labeled leukocytes PET/MRI

Healthy Controls

Experimental group

Treatment:

Drug: [Zr-89]Oxine-labeled leukocytes PET/MRI