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

Healthy Clinical Trial

— DPA-714  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03759522
• Other study ID #: R18-118
• Status: Recruiting
• Phase: Phase 1
• Start date: February 3, 2019
• Est. completion date: April 10, 2025

Study information

• Verified date: December 2023
• Source: University of Alabama at Birmingham
• Contact: Jared Younger, PhD
• Phone: 205-975-5907
• Email: youngerlab[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 10, 2025
• Est. primary completion date: April 10, 2025
• 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 ß-hCG test day of procedure or a serum -hCG test within 48 hours prior to the administration of [18F]DPA-714

11. Currently enrolled in a clinical trial utilizing experimental therapies

Related Conditions & MeSH terms

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

Intervention

Drug:
• DPA-714 PET/MRI
DPA-714 PET/MRI

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham Medical Center	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	Neuroinflammation will be measured in healthy volunteers and compared to neuroinflammation in individuals with pain and fatigue, as measured with [F-18]DPA-714-PET/MRI.	Quantitative PET measures of TSPO binding in brain regions including cerebral cortex, thalami, and brainstem will be compared between healthy volunteers and symptomatic study participants with pain and/or fatigue.	3 years