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

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03759522
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 58.9
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia; Chronic Fatigue Syndrome; Multiple Sclerosis; Healthy	Drug: DPA-714 PET/MRI	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.
• Actual Study Start Date: Feb 3, 2019
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy Controls	Drug: DPA-714 PET/MRI; DPA-714 PET/MRI
Experimental: Fibromyalgia Subjects	Drug: DPA-714 PET/MRI; DPA-714 PET/MRI
Experimental: Chronic Fatigue Syndrome Subjets	Drug: DPA-714 PET/MRI; DPA-714 PET/MRI
Experimental: Multiple Sclerosis Subjects	Drug: DPA-714 PET/MRI; DPA-714 PET/MRI

Outcome Measures

Primary Outcome Measures

1. 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. [3 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 β-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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Medical Center	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jonathan E McConathy, M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03759522
• Other Study ID Numbers: R18-118
• First Posted: Nov 30, 2018
• Last Update Posted: Dec 6, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fatigue Syndrome, Chronic; Fibromyalgia; Multiple Sclerosis

Study Results

No Results Posted as of Dec 6, 2021