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Leukocyte Tracking PET/MRI for Multiple Sclerosis

Phase 1
Recruiting
Led By Jonathan McConathy, MD,PhD
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
Meets 1994 Fukuda case definition criteria for Chronic Fatigue Syndrome
18 to 65 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial will use PET/MRI to track white blood cells in people with conditions associated with brain inflammation. The hope is that by understanding neuroinflammation better, patients can be better diagnosed and treated in the future.

Who is the study for?
This trial is for people aged 18-65 with fibromyalgia, chronic fatigue syndrome, multiple sclerosis, or healthy volunteers. It's not for those who are pregnant or lactating, have cancer, blood disorders, severe medical conditions preventing imaging procedures, recent serious infections, chronic infectious diseases like HIV/HCV or other autoimmune diseases (except MS).Check my eligibility
What is being tested?
[Zr-89]Oxine-labeled leukocytes PET/MRI is being tested to track white blood cells in the body and see if they move into the brain in patients with neuroinflammation-related conditions such as fibromyalgia and multiple sclerosis.See study design
What are the potential side effects?
Potential side effects may include reactions to the radioactive drug [Zr-89]oxine or MRI contrast agents used during imaging. There might also be risks associated with exposure to radiation from the PET scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Chronic Fatigue Syndrome.
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I am between 18 and 65 years old.
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I have been diagnosed with Multiple Sclerosis.

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
Regional brain distribution of radiolabeled white blood cells

Trial Design

4Treatment groups
Experimental Treatment
Group I: Multiple SclerosisExperimental Treatment1 Intervention
Group II: Healthy ControlsExperimental Treatment1 Intervention
Group III: FibromyalgiaExperimental Treatment1 Intervention
Group IV: Chronic Fatigue SyndromeExperimental Treatment1 Intervention

Find a Location

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
6 Trials studying Fibromyalgia
40,222 Patients Enrolled for Fibromyalgia
Jonathan McConathy, MD,PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

[Zr-89]Oxine-labeled leukocytes PET/MRI Clinical Trial Eligibility Overview. Trial Name: NCT03807973 — Phase 1
Fibromyalgia Research Study Groups: Multiple Sclerosis, Fibromyalgia, Healthy Controls, Chronic Fatigue Syndrome
Fibromyalgia Clinical Trial 2023: [Zr-89]Oxine-labeled leukocytes PET/MRI Highlights & Side Effects. Trial Name: NCT03807973 — Phase 1
[Zr-89]Oxine-labeled leukocytes PET/MRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT03807973 — Phase 1

Frequently Asked Questions

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

Is there an ongoing call for volunteers to participate in this research?

"Affirmative. Per the information hosted on clinicaltrials.gov, this research project is actively searching for participants after having been first posted October 5th 2021 and lastly updated January 3rd 2022. The trial requires 120 individuals from a singular site to partake in it."

Answered by AI

Is participation in the research open to octogenarians?

"For this clinical trial, only people within the age bracket of 18 to 65 are suitable candidates. For those under 18 and over 65, 83 studies and 696 studies respectively have been conducted."

Answered by AI

Could you give me an overview of the current research surrounding [Zr-89]Oxine-labeled leukocytes PET/MRI?

"Currently, one [Zr-89]Oxine-labeled leukocytes PET/MRI clinical trial is underway and it has not yet reached Phase 3. This study is primarily based in Birmingham, Alabama but there are additional sites where the treatment can be accessed."

Answered by AI

Has the [Zr-89]Oxine-labeled leukocytes PET/MRI been sanctioned by the FDA?

"The safety rating of [Zr-89]Oxine-labeled leukocytes PET/MRI was assessed at a 1, as this is an early phase trial with limited evidence demonstrating both efficacy and security."

Answered by AI

Who is eligible to participate in this research initiative?

"Eligible patients must have fibromyalgia, be of legal age and under 65 years old. A total of 120 individuals are being recruited for the trial."

Answered by AI

What is the enrollment rate for this experimental research project?

"Indeed, clinicaltrials.gov has indicated that this research project is still recruiting participants. The trial was published on October 5th 2021 and was last updated in January 3rd 2022; it requires 120 volunteers across one site to take part."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
Mississippi
What site did they apply to?
UAB
How many prior treatments have patients received?
3+
~17 spots leftby Oct 2024