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

Primary Purpose

Fibromyalgia, Chronic Fatigue Syndrome, Multiple Sclerosis

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

DPA-714 PET/MRI

About this trial

This is an interventional diagnostic trial for Fibromyalgia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

18 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

Exclusion Criteria:

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
Except for individuals with MS, a diagnosis of autoimmune disease is exclusionary
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

Sites / Locations

University of Alabama at Birmingham Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Healthy Controls

Fibromyalgia Subjects

Chronic Fatigue Syndrome Subjets

Multiple Sclerosis Subjects

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03759522

First Posted

November 6, 2018

Last Updated

November 9, 2022

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT03759522

Brief Title

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

Acronym

DPA-714

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 3, 2019 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia, Chronic Fatigue Syndrome, Multiple Sclerosis, Healthy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy Controls

Arm Type

Experimental

Arm Title

Fibromyalgia Subjects

Arm Type

Experimental

Arm Title

Chronic Fatigue Syndrome Subjets

Arm Type

Experimental

Arm Title

Multiple Sclerosis Subjects

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

DPA-714 PET/MRI

Intervention Description

DPA-714 PET/MRI

Primary Outcome Measure Information:

Title

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.

Description

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 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 Exclusion Criteria: 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 Except for individuals with MS, a diagnosis of autoimmune disease is exclusionary 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jared Younger, PhD

Phone

205-975-5907

youngerlab@uab.edu

Facility Information:

Facility Name

University of Alabama at Birmingham Medical Center

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Individual Site Status

Recruiting

Facility Contact: