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

Phase 1

Recruiting

• Conditions: Healthy; Chronic Fatigue Syndrome; Multiple Sclerosis; Fibromyalgia
• Interventions: Drug: [Zr-89]Oxine-labeled leukocytes PET/MRI

• Registration Number: NCT03807973
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-17
• Study Start: 2021-10-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-04
• Primary Completion: 2028-10
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fibromyalgia	[Zr-89]Oxine-labeled leukocytes PET/MRI	-
Healthy Controls	[Zr-89]Oxine-labeled leukocytes PET/MRI	-
Chronic Fatigue Syndrome	[Zr-89]Oxine-labeled leukocytes PET/MRI	-
Multiple Sclerosis	[Zr-89]Oxine-labeled leukocytes PET/MRI	-

Primary Outcome Measures

Name	Time	Method
Regional brain distribution of radiolabeled white blood cells	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.

Trial Locations

Locations (1)

UAB; 🇺🇸 Birmingham, Alabama, United States