FibromyalgiaPhase 1NCT03807973
Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.
A Phase 1 study testing [Zr-89]Oxine-labeled leukocytes PET/MRI in people with Fibromyalgia and Chronic Fatigue Syndrome, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Chronic Fatigue Syndrome, Multiple Sclerosis
- What is being tested?
- [Zr-89]Oxine-labeled leukocytes PET/MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2021to Oct 2028
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindication to MRI
- Pregnancy
- Lactation
- 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
Show all 12Show fewer
- Diagnosis of cancer, including leukemia
- Blood or blood clotting disorder
- Except for individuals with MS, a diagnosis of autoimmune disease is exclusionary
- 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
- Currently enrolled in a clinical trial utilizing experimental therapies
- Contraindication to gadolinium based contrast agents
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Fibromyalgia, Chronic Fatigue Syndrome, Multiple Sclerosis, Healthy
- Being tested
- [Zr-89]Oxine-labeled leukocytes PET/MRI
- Medical subject headings
- Fibromyalgia, Fatigue Syndrome, Chronic, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[Zr-89]Oxine-labeled leukocytes PET/MRIDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia | Experimental | Not described Receives: Drug: [Zr-89]Oxine-labeled leukocytes PET/MRI |
| Chronic Fatigue Syndrome | Experimental | Not described Receives: Drug: [Zr-89]Oxine-labeled leukocytes PET/MRI |
| Multiple Sclerosis | Experimental | Not described Receives: Drug: [Zr-89]Oxine-labeled leukocytes PET/MRI |
| Healthy Controls | Experimental | Not described Receives: Drug: [Zr-89]Oxine-labeled leukocytes PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start5 Oct 2021
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Why it stopped: Lost funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan E McConathy, University of Alabama at Birmingham
- Investigators
- Jonathan McConathy, MD,PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807973
- Sponsor's protocol ID
- IRB-300004369 R18-179
- Other IDs
- ME Research UK
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2019
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 42825819
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.
- ClinicalTrials.gov ID
- NCT03807973
- Acronym / sponsor ID
- IRB-300004369 R18-179
- Conditions
- Fibromyalgia, Chronic Fatigue Syndrome, Multiple Sclerosis, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Lost funding.
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 17 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia | Experimental | Drug: [Zr-89]Oxine-labeled leukocytes PET/MRI |
| Chronic Fatigue Syndrome | Experimental | Drug: [Zr-89]Oxine-labeled leukocytes PET/MRI |
| Multiple Sclerosis | Experimental | Drug: [Zr-89]Oxine-labeled leukocytes PET/MRI |
| Healthy Controls | Experimental | Drug: [Zr-89]Oxine-labeled leukocytes PET/MRI |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Contraindication to MRI
- Pregnancy
- Lactation
- Individuals who are unable to participate in the imaging portion due to severity of their medical condition
- Chronic infectious disease (e.g. HIV, HCV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [Zr-89]Oxine-labeled leukocytes PET/MRIAll 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. | Drug | Chronic Fatigue Syndrome, Fibromyalgia, Healthy Controls, Multiple Sclerosis |
Primary outcome
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 normal distribution if necessary.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Derived from this study: PubMed 42825819Gultekin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan McConathy, MD,PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [Zr-89]Oxine-labeled leukocytes PET/MRI in people with Fibromyalgia and Chronic Fatigue Syndrome, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional brain distribution of radiolabeled white blood cells (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03807973, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.