PausedPhase 1MS (type not specified)NCT03807973

What it found

Still running

No result yet.

Reason given: Lost funding.

What was tested

Treatment tested

  • [Zr-89]Oxine-labeled leukocytes PET/MRI

What it measured

Main measures

  • Regional brain distribution of radiolabeled white blood cells

    3 years

    MRI lesionsBrain volume loss

Who could take part

MS (type not specified) · 18 to 65

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Oct 2021

    2. Main results due

      Oct 2028

    3. Finished

      Oct 2028

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