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

NCT ID: NCT03759522

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-03

Study Completion Date

2026-04-10

Brief Summary

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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.

Detailed Description

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Conditions

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Fibromyalgia Chronic Fatigue Syndrome Multiple Sclerosis Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy Controls

Group Type EXPERIMENTAL

DPA-714 PET/MRI

Intervention Type DRUG

DPA-714 PET/MRI

Fibromyalgia Subjects

Group Type EXPERIMENTAL

DPA-714 PET/MRI

Intervention Type DRUG

DPA-714 PET/MRI

Chronic Fatigue Syndrome Subjets

Group Type EXPERIMENTAL

DPA-714 PET/MRI

Intervention Type DRUG

DPA-714 PET/MRI

Multiple Sclerosis Subjects

Group Type EXPERIMENTAL

DPA-714 PET/MRI

Intervention Type DRUG

DPA-714 PET/MRI

Interventions

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DPA-714 PET/MRI

DPA-714 PET/MRI

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Jonathan E McConathy

M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alabama at Birmingham Medical Center

Birmingham, Alabama, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jared Younger, PhD

Role: CONTACT

Phone: 205-975-5907

Email: [email protected]

Facility Contacts

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Jonathan McConathy, MD

Role: primary

Jonathan McConathy, MD, PhD

Role: backup

Bag Asim, MD

Role: backup

Bhambhvani Pradeep, MD

Role: backup

Choudhary Gagandeep, MD

Role: backup

Geldmacher David, MD

Role: backup

Lapi Suzanne, PhD

Role: backup

Jeffers Charlotte Denise, RPh

Role: backup

Natelson Marissa, MD

Role: backup

Roberson Erik, MD, PhD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 37326674 (View on PubMed)

Other Identifiers

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R18-118

Identifier Type: -

Identifier Source: org_study_id