NCT03759522

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
24mo left

Started Feb 2019

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Feb 2019Apr 2028

First Submitted

Initial submission to the registry

November 6, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 30, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 3, 2019

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

9.2 years

First QC Date

November 6, 2018

Last Update Submit

February 17, 2026

Conditions

FibromyalgiaChronic Fatigue SyndromeMultiple SclerosisHealthy

Outcome Measures

Primary Outcomes (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.

    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

Study Arms (4)

Healthy Controls

EXPERIMENTAL
Drug: DPA-714 PET/MRI

Fibromyalgia Subjects

EXPERIMENTAL
Drug: DPA-714 PET/MRI

Chronic Fatigue Syndrome Subjets

EXPERIMENTAL
Drug: DPA-714 PET/MRI

Multiple Sclerosis Subjects

EXPERIMENTAL
Drug: DPA-714 PET/MRI

Interventions

DPA-714 PET/MRIDRUG

DPA-714 PET/MRI

Chronic Fatigue Syndrome SubjetsFibromyalgia SubjectsHealthy ControlsMultiple Sclerosis Subjects

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 65 years of age
  • 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 β-hCG test day of procedure or a serum -hCG test within 48 hours prior to the administration of \[18F\]DPA-714
  • Currently enrolled in a clinical trial utilizing experimental therapies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, 35294, United States

RECRUITING

Related Publications (1)

  • Mueller C, Fang YD, Jones C, McConathy JE, Raman F, Lapi SE, Younger JW. Evidence of neuroinflammation in fibromyalgia syndrome: a [ 18 F]DPA-714 positron emission tomography study. Pain. 2023 Oct 1;164(10):2285-2295. doi: 10.1097/j.pain.0000000000002927. Epub 2023 Jun 15.

    PMID: 37326674DERIVED

MeSH Terms

Conditions

FibromyalgiaFatigue Syndrome, ChronicMultiple Sclerosis

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesEncephalomyelitisNeuroinflammatory DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Jared Younger, PhD

CONTACT

205-975-5907youngerlab@uab.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics

Study Record Dates

First Submitted

November 6, 2018

First Posted

November 30, 2018

Study Start

February 3, 2019

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

February 20, 2026

Record last verified: 2026-02

Locations

US(1)