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NCT03807973

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

Suspended Phase 1 Last updated 30 May 2026
What this trial tests

Phase 1 trial testing [Zr-89]Oxine-labeled leukocytes PET/MRI in Fibromyalgia in 120 participants. Suspended.

Timeline
5 October 2021
Primary endpoint
1 October 2028
1 October 2028

Quick facts

Lead sponsorUniversity of Alabama at Birmingham
PhasePhase 1
StatusSuspended
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposediagnostic
Enrollment120
Start date5 October 2021
Primary completion1 October 2028
Estimated completion1 October 2028
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Alabama at Birmingham

Who can join

Adults 18 to 65, any sex, with Fibromyalgia or Chronic Fatigue Syndrome. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Translational molecular imaging and drug development in multiple sclerosis.
    Tay D, Ahmed H, Dawoud A, Salam M, et al · · 2026 · PMID 41356192 · DOI 10.7150/thno.119559

Verify or expand the search:

Other recruiting trials for Fibromyalgia

Currently open trials in the same condition.

Other University of Alabama at Birmingham trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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