RECRUITING

Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.

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

The primary objective of this study is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET radiopharmaceutical \[F-18\]DPA-714 in individuals with chronic pain and fatigue suspected to be associated with neuroinflammation. The PET tracer \[F-18\]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The primary objective of this study is to determine if pain and fatigue patients have higher levels of neuroinflammation than HC individuals as measured with \[F-18\]DPA-714-PET/MRI.

Official Title

Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.

Quick Facts

Study Start:2019-02-03
Study Completion:2025-04-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03759522

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. 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
  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 β-hCG test day of procedure or a serum -hCG test within 48 hours prior to the administration of \[18F\]DPA-714
  11. 11. Currently enrolled in a clinical trial utilizing experimental therapies

Contacts and Locations

Study Contact

Jared Younger, PhD
CONTACT
205-975-5907
youngerlab@uab.edu

Study Locations (Sites)

University of Alabama at Birmingham Medical Center
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: 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 Date2019-02-03
Study Completion Date2025-04-10

Study Record Updates

Study Start Date2019-02-03
Study Completion Date2025-04-10

Terms related to this study

Additional Relevant MeSH Terms

  • Fibromyalgia
  • Chronic Fatigue Syndrome
  • Multiple Sclerosis
  • Healthy