Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using… (NCT03807973) | Clinical Trial Compass
SuspendedPhase 1
Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.
Stopped: Lost funding.
United States120 participantsStarted 2021-10-05
Plain-language summary
This study will use brain Positron Emission Tomography/ Magnetic Resonance Imaging (PET/MRI) and an investigational radioactive drug called \[Zr-89\]oxine to track the location of white blood cells (also called leukocytes) in the body. PET/MRI will be used to visualize labeled white blood cells and determine if they enter the central nervous system in conditions associated with brain inflammation (also called neuroinflammation). By better understanding the role of neuroinflammation in fibromyalgia, chronic fatigue syndrome, and multiple sclerosis, the investigator hopes to be able to better diagnose and treat patients in the future.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
.18 to 65 years of age 2.Healthy volunteer OR
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is currently suspended — do you know why it was paused, and whether that affects what we currently understand about the safety of the Zr-89 radiolabeled white blood cell approach?
2Since this is a Phase 1 study, it's mainly designed to see if the imaging technique is safe and feasible rather than to treat my condition — does that mean there's no direct treatment benefit I should expect from participating?
3The trial involves labeling my own white blood cells with a radioactive tracer and reinjecting them — what are the specific risks of radiation exposure I should be aware of, and how does that compare to other scans I might already be having?
4Given that this study covers very different conditions like fibromyalgia, chronic fatigue syndrome, and multiple sclerosis, how would the information gathered about immune cell activity in my brain actually be relevant to my specific diagnosis and care?
5Are there other diagnostic imaging studies or treatment trials actively enrolling right now that might be a better fit for me, given that this one is currently suspended?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Regional brain distribution of radiolabeled white blood cells