NCT03807973|SuspendedPhase 1DMCFDA Drug
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · ME Research UK
interventional
120
1 country
1
Study Start
October 5, 2021
Actual (reported)Primary Completion
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 14, 2019
Actual (reported)January 17, 2019
Actual (reported)October 5, 2021
Actual (reported)October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Regional brain distribution of radiolabeled white blood cells
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.
3 years
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UAB
Birmingham, Alabama, 35294, United States
Gultekin K, Bartels JL, Cardenas CE, Kumar Y, Gimblet GR, Jones CL, Bankston C, Jeffers CD, White SL, Lapi SE, Younger JW, McConathy JE. First-in-human dosimetry and biodistribution of [89Zr]Zr-oxine-labeled autologous leukocytes using PET/CT. Eur J Nucl Med Mol Imaging. 2026 Oct 2. doi: 10.1007/s00259-026-08158-w. Online ahead of print.
Jonathan McConathy, MD,PhD
University of Alabama at Birmingham
First Submitted
January 14, 2019
First Posted
January 17, 2019
Study Start
October 5, 2021
Actual (reported)Primary Completion
October 2028
EstimatedA Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of IMS001 in Subjects With Multiple Sclerosis
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 2, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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