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NCT03807973SuspendedPhase 1

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

Source: ClinicalTrials.gov · Last updated 2 Jun 2026

Reason given: Lost funding.

Brief summary (registry, in English)

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.

Status (registry)
Suspended
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
120 (estimated)
First submitted
14 Jan 2019
Start date
5 Oct 2021
Primary completion date
Oct 2028
Lead sponsor
University of Alabama at Birmingham
NCT number
NCT03807973

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently enrolled in a clinical trial utilizing experimental therapies

Other illness

  • 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

Lab values

  • 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

Other

  • Contraindication to MRI
  • Pregnancy
  • Lactation
  • Contraindication to gadolinium based contrast agents

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
UABBirminghamUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.