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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Fibromyalgia
  • Drug: [Zr-89]Oxine-labeled leukocytes PET/MRI
    All study participants will undergo an investigational imaging study using autologous [Zr-89]-labeled leukocytes and brain PET/MRI. Participants will undergo a venous blood draw, and the leukocytes in the blood sample will be isolated for labeling using [Zr-89]oxine. The labeled leukocytes (7.4- 18.5 megabecquerel (MBq), 200-500 uCi) will be re-injected into the participant followed by brain PET/MRI at 24-48 hours after injection. Participants will be asked to have a second brain imaging study 3-6 days after this injection, but this second imaging study is optional.
Experimental
Chronic Fatigue Syndrome
  • Drug: [Zr-89]Oxine-labeled leukocytes PET/MRI
    All study participants will undergo an investigational imaging study using autologous [Zr-89]-labeled leukocytes and brain PET/MRI. Participants will undergo a venous blood draw, and the leukocytes in the blood sample will be isolated for labeling using [Zr-89]oxine. The labeled leukocytes (7.4- 18.5 megabecquerel (MBq), 200-500 uCi) will be re-injected into the participant followed by brain PET/MRI at 24-48 hours after injection. Participants will be asked to have a second brain imaging study 3-6 days after this injection, but this second imaging study is optional.
Experimental
Multiple Sclerosis
  • Drug: [Zr-89]Oxine-labeled leukocytes PET/MRI
    All study participants will undergo an investigational imaging study using autologous [Zr-89]-labeled leukocytes and brain PET/MRI. Participants will undergo a venous blood draw, and the leukocytes in the blood sample will be isolated for labeling using [Zr-89]oxine. The labeled leukocytes (7.4- 18.5 megabecquerel (MBq), 200-500 uCi) will be re-injected into the participant followed by brain PET/MRI at 24-48 hours after injection. Participants will be asked to have a second brain imaging study 3-6 days after this injection, but this second imaging study is optional.
Experimental
Healthy Controls
  • Drug: [Zr-89]Oxine-labeled leukocytes PET/MRI
    All study participants will undergo an investigational imaging study using autologous [Zr-89]-labeled leukocytes and brain PET/MRI. Participants will undergo a venous blood draw, and the leukocytes in the blood sample will be isolated for labeling using [Zr-89]oxine. The labeled leukocytes (7.4- 18.5 megabecquerel (MBq), 200-500 uCi) will be re-injected into the participant followed by brain PET/MRI at 24-48 hours after injection. Participants will be asked to have a second brain imaging study 3-6 days after this injection, but this second imaging study is optional.

Recruiting Locations

UAB
Birmingham, Alabama 35294
Contact:
Evan Hudson, BS
205-934-6499
evanhudson@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Jonathan McConathy, MD, PhD
205-996-7115
jmcconathy@uabmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.