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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 February 2024
• Main ID: NCT03807973
• Date of registration: 14/01/2019
• Prospective Registration: Yes
• Primary sponsor: University of Alabama at Birmingham
• Public title: Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.
• Scientific title: Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.
• Date of first enrolment: October 5, 2021
• Target sample size: 120
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03807973
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Evan Hudson, BS

• Name: Jonathan McConathy, MD, PhD

• Name: Jonathan McConathy, MD,PhD
• Affiliation: University of Alabama at Birmingham

Key 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Fibromyalgia

Chronic Fatigue Syndrome

Multiple Sclerosis

Intervention(s)

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

Primary Outcome(s)

Regional brain distribution of radiolabeled white blood cells [Time Frame: 3 years]

Secondary ID(s)

R18-179

Source(s) of Monetary Support

Please refer to primary and secondary sponsors