RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-10-05
Study Completion:2028-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03807973

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1.18 to 65 years of age 2.Healthy volunteer OR
  2. * Clinical diagnosis of Multiple Sclerosis (MS) OR
  3. * Meets 2016 American College of Rheumatology (ACR) case definition criteria for fibromyalgia OR
  4. * Meets 1994 Fukuda case definition criteria for Chronic Fatigue Syndrome
  1. 1. Contraindication to MRI
  2. 2. Pregnancy
  3. 3. Lactation
  4. 4. Individuals who are unable to participate in the imaging portion due to severity of their medical condition
  5. 5. Chronic infectious disease (e.g. HIV, HCV)
  6. 6. Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
  7. 7. Diagnosis of cancer, including leukemia
  8. 8. Blood or blood clotting disorder
  9. 9. Except for individuals with MS, a diagnosis of autoimmune disease is exclusionary
  10. 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. 11. Currently enrolled in a clinical trial utilizing experimental therapies
  12. 12. Contraindication to gadolinium based contrast agents

Contacts and Locations

Study Contact

Jonathan McConathy, MD, PhD
CONTACT
205-996-7115
jmcconathy@uabmc.edu
Evan Hudson, BS
CONTACT
205-934-6499
evanhudson@uabmc.edu

Principal Investigator

Jonathan McConathy, MD,PhD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

UAB
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Jonathan McConathy, MD,PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-05
Study Completion Date2028-10

Study Record Updates

Study Start Date2021-10-05
Study Completion Date2028-10

Terms related to this study

Additional Relevant MeSH Terms

  • Fibromyalgia
  • Chronic Fatigue Syndrome
  • Multiple Sclerosis
  • Healthy