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

NCT03807973 | Suspended Phase 1 DMC FDA Drug

• 2 other identifiers: R18-179ME Research UK
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Chronic Fatigue Syndrome; Multiple Sclerosis; Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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

Interventions

[Zr-89]Oxine-labeled leukocytes PET/MRI DRUG

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.

Chronic Fatigue Syndrome; Fibromyalgia; Healthy Controls; Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Diagnosis of cancer, including leukemia
• Blood or blood clotting disorder
• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Fatigue Syndrome, Chronic; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jonathan McConathy, MD,PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Director for the Division Molecular Imaging and Therapeutics

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 17, 2019
• Study Start: October 5, 2021
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

US (1)