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NCT03807973
Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.
Phase 1 trial testing [Zr-89]Oxine-labeled leukocytes PET/MRI in Fibromyalgia in 120 participants. Suspended.
1 October 2028
Quick facts
| Lead sponsor | University of Alabama at Birmingham |
|---|---|
| Phase | Phase 1 |
| Status | Suspended |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 120 |
| Start date | 5 October 2021 |
| Primary completion | 1 October 2028 |
| Estimated completion | 1 October 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- [Zr-89]Oxine-labeled leukocytes PET/MRI — full drug profile →
Conditions studied
- Fibromyalgia — all drugs for Fibromyalgia →
- Chronic Fatigue Syndrome — all drugs for Chronic Fatigue Syndrome →
- Multiple Sclerosis — all drugs for Multiple Sclerosis →
- Healthy — all drugs for Healthy →
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.
-
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 norm
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):
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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:
- PubMed search for NCT03807973
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Alabama at Birmingham trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03807973 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Alabama at Birmingham
- Last refreshed: 30 May 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03807973.
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