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

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ClinicalTrials.gov Identifier: NCT03807973
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
Jonathan E McConathy, University of Alabama at Birmingham

Study Description
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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 (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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Chronic Fatigue Syndrome Multiple Sclerosis Healthy Drug: [Zr-89]Oxine-labeled leukocytes PET/MRI Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.
Actual Study Start Date : October 5, 2021
Estimated Primary Completion Date : October 5, 2023
Estimated Study Completion Date : October 5, 2024

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Regional brain distribution of radiolabeled white blood cells [ Time Frame: 3 years ]
    Descriptive statistics (means and standard deviations) of standardized uptake values (SUVs) will be presented for the patient groups and healthy controls in the following regions: whole brain, gray matter, white matter, atlas-based regions of interest, and lesions (MS patients only). Normality of the SUV distribution will be tested using Shapiro-Wilk tests, and the data will be transformed to normal distribution if necessary.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807973


Contacts
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Contact: Jonathan McConathy, MD, PhD 205-996-7115 jmcconathy@uabmc.edu
Contact: Evan Hudson, BS 205-934-6499 evanhudson@uabmc.edu

Locations
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United States, Alabama
UAB Recruiting
Birmingham, Alabama, United States, 35294
Contact: Evan Hudson, BS    205-934-6499    evanhudson@uabmc.edu   
Principal Investigator: Jonathan McConathy, MD,PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Jonathan McConathy, MD,PhD University of Alabama at Birmingham
More Information
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Responsible Party: Jonathan E McConathy, MD, PhD, Director for the Division Molecular Imaging and Therapeutics, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03807973    
Other Study ID Numbers: R18-179
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: January 19, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Fibromyalgia
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
 Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Virus Diseases
Infections
Encephalomyelitis
Central Nervous System Diseases