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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

1. Contraindication to MRI. 2. Pregnancy. 3. Lactation. 4. Individuals who are unable to participate in the imaging portion due to severity of their medical condition. 5. Chronic infectious disease (e.g. HIV, HCV) 6. Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation. 7. Diagnosis of cancer, including leukemia. 8. Blood or blood clotting disorder. 9. Except for individuals with MS, a diagnosis of autoimmune disease is exclusionary. 10. 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. 11. Currently enrolled in a clinical trial utilizing experimental therapies. 12. Contraindication to gadolinium based contrast agents

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03807973
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Alabama at Birmingham
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jonathan McConathy, MD,PhD
Principal Investigator Affiliation University of Alabama at Birmingham
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Fibromyalgia, Chronic Fatigue Syndrome, Multiple Sclerosis, Healthy
Arms & Interventions

Arms

Experimental: Fibromyalgia

Experimental: Chronic Fatigue Syndrome

Experimental: Multiple Sclerosis

Experimental: Healthy Controls

Interventions

Drug: - [Zr-89]Oxine-labeled leukocytes PET/MRI

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UAB, Birmingham, Alabama

Status

Recruiting

Address

UAB

Birmingham, Alabama, 35294

Site Contact

Evan Hudson, BS

[email protected]

205-934-6499