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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
Must not have
Except for individuals with MS, a diagnosis of autoimmune disease is exclusionary
Blood or blood clotting disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

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).
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have an autoimmune disease, except for MS.
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I have a blood or clotting disorder.
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I have a long-term infection like HIV or hepatitis C.
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I haven't had a serious infection needing treatment in the last month.
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I have been diagnosed with cancer, including leukemia.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Regional brain distribution of radiolabeled white blood cells

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,646 Previous Clinical Trials
2,342,264 Total Patients Enrolled
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
Musculoskeletal Disease Research Study Groups: Multiple Sclerosis, Fibromyalgia, Healthy Controls, Chronic Fatigue Syndrome
Musculoskeletal Disease 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
~67 spots leftby Oct 2028
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