Ultra-Low Field (ULF) Point-of-Care (POC) MRI System for Brain Morphology and Pathology (NCT06203626) | Clinical Trial Compass
RecruitingNot Applicable
Ultra-Low Field (ULF) Point-of-Care (POC) MRI System for Brain Morphology and Pathology
United States200 participantsStarted 2024-03-26
Plain-language summary
Background:
Magnetic resonance imaging (MRI) is a tool for getting pictures of the tissues and organs inside the body. MRI can help diagnose many injuries and diseases. But not all patients are equally likely to receive MRIs. Factors such as race or ethnicity, distance to imaging centers, mobility, and a lower income can limit some people s access to MRIs. A new ultra-low field (ULF) type of MRI, which can be used on a vehicle, may help take imaging scans to more people. But researchers need to know that UFL-MRI works just as well as standard MRIs.
Objective:
To learn whether UFL-MRI is as good as standard MRI at detecting neurological disorders.
Eligibility:
People aged 3 years or older who have or show symptoms of neurological disease (such as stroke, cancer, or epilepsy). Healthy adults are also needed.
Design:
Participants will have 1 or 2 study visits.
Adult participants will have a physical exam. They will receive two MRI exams:
* Standard MRI. They will lie still on a narrow bed that will move into a large tube. They will wear earplugs to muffle the sounds.
* ULF-MRI. They will lie on a stretcher, and only their head will be inside a smaller tube. The noises will be quieter. They will wear earplugs to muffle the sounds.
Some adults may receive a contrast agent given through a small tube attached to a needle in the arm. The contrast agent helps the researchers see differences in the body more clearly. This may be done during 1 or both MRIs.
Children will have only 1 ULF-MRI.
Some participants may be invited to have additional visits for up to 6 months.
Who can participate
Age range
3 Years – 99 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:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Volunteer of any gender, 3 years of age and older.
* Adult participant: must be capable of understanding the procedures and requirements of this study and be able and willing to sign an informed consent document.
* Minor participant: Must have a parent or guardian capable of understanding the procedures and requirements of this study who are willing to sign an informed parental consent document, and where feasible, the minor age 7 and older provides assent.
* Either:
* Adult in good general health as evidenced by medical history or
* Diagnosed with a stroke, a neurological or neuro-oncological disease, or
* Exhibiting symptoms suggestive of neurological or neuro-oncological disease.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
* Unable to undergo MRI study based on screening (e.g., presence of non-MRI compatible objects).
* Pregnancy or lactation, if contrast agent is required.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
ULF-MRI sensitivity to detect presence of pathology
Timeframe: Visit 1 and optional visit two within 180 days.
2
Technical development
Timeframe: Visit 1 and optional repeated visits through the life of the protocol.
Trial details
NCT IDNCT06203626
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)