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PET Radiopharmaceutical

DPA-714 PET/MRI for Chronic Pain and Fatigue (DPA-714 Trial)

Phase 1
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 to 65 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

DPA-714 Trial Summary

This trial is testing a new way to measure neuroinflammation in people with chronic pain and fatigue, which may be caused by neuroinflammation. The new method uses a PET tracer that binds to a protein in the mitochondria of activated microglia/macrophages. The trial will compare levels of neuroinflammation in patients and healthy controls.

Who is the study for?
This trial is for adults aged 18-65 who are healthy or have a diagnosis of Multiple Sclerosis, meet criteria for fibromyalgia or Chronic Fatigue Syndrome. It's not suitable for pregnant or lactating individuals, those with MRI contraindications, severe medical conditions preventing imaging participation, chronic infections like HIV/HCV, recent acute illness requiring antibiotics, cancer diagnoses, blood disorders, autoimmune diseases (except MS), or current involvement in trials with experimental therapies.Check my eligibility
What is being tested?
The study tests how a PET radiopharmaceutical called [F-18]DPA-714 maps brain inflammation in patients with chronic pain and fatigue versus healthy controls. The drug binds to specific proteins in activated immune cells within the brain to visualize neuroinflammation using PET/MRI technology.See study design
What are the potential side effects?
As this trial involves diagnostic imaging rather than medication administration directly targeting disease symptoms or progression, typical side effects associated with drugs may not be applicable here. However general risks related to PET/MRI procedures may include discomfort at injection site and potential allergic reactions to the tracer.

DPA-714 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

DPA-714 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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.

DPA-714 Trial Design

4Treatment groups
Experimental Treatment
Group I: Multiple Sclerosis SubjectsExperimental Treatment1 Intervention
Group II: Healthy ControlsExperimental Treatment1 Intervention
Group III: Fibromyalgia SubjectsExperimental Treatment1 Intervention
Group IV: Chronic Fatigue Syndrome SubjetsExperimental Treatment1 Intervention

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,234 Total Patients Enrolled
37 Trials studying Multiple Sclerosis
45,163 Patients Enrolled for Multiple Sclerosis

Media Library

DPA-714 PET/MRI (PET Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT03759522 — Phase 1
Multiple Sclerosis Research Study Groups: Healthy Controls, Fibromyalgia Subjects, Chronic Fatigue Syndrome Subjets, Multiple Sclerosis Subjects
Multiple Sclerosis Clinical Trial 2023: DPA-714 PET/MRI Highlights & Side Effects. Trial Name: NCT03759522 — Phase 1
DPA-714 PET/MRI (PET Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03759522 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration granted approval for DPA-714 PET/MRI?

"DPA-714 PET/MRI is provisionally classified as 1 due to limited data supporting both safety and efficacy, which comes from a Phase 1 trial."

Answered by AI

Are there still vacancies for this clinical trial?

"According to clinicaltrials.gov, this research endeavour is still actively recruiting participants. It was first posted on February 3rd 2019 and the listing has been updated most recently on November 9th 2022."

Answered by AI

How many participants are currently involved in this experiment?

"Affirmative. According to the clinicaltrials.gov database, this experiment is actively recruiting participants; it was first posted on February 3rd 2019 and recently modified November 9th 2022. 120 volunteers are required in a single participating medical center."

Answered by AI

Does your research encompass individuals that are fifty or older?

"This clinical trial is restricted to those aged 18-65. There are separate 83 trials for juvenile patients and 695 studies enrolling elderly individuals."

Answered by AI

What are the eligibility criteria for persons to join this clinical experimentation?

"This clinical trial seeks 120 participants aged 18 to 65 with either Multiple sclerosis, Fibromyalgia meeting the American College of Rheumatology criteria or Chronic fatigue syndrome in accordance to Fukuda's 1994 guidelines."

Answered by AI

Who else is applying?

What site did they apply to?
University of Alabama at Birmingham Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
~18 spots leftby Apr 2025