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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03807973
• Other study ID #: R18-179
• Status: Recruiting
• Phase: Phase 1
• Start date: October 5, 2021
• Est. completion date: October 5, 2025

Study information

• Verified date: February 2024
• Source: University of Alabama at Birmingham
• Contact: Jonathan McConathy, MD, PhD
• Phone: 205-996-7115
• Email: jmcconathy[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 5, 2025
• Est. primary completion date: October 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue Syndrome, Chronic
• Fibromyalgia
• Healthy
• Multiple Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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