NCT06203626 · National Institute of Neurological Disorders and Stroke (NINDS)
Ultra-Low Field (ULF) Point-of-Care (POC) MRI System for Brain Morphology and Pathology
What this study is about
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.
View original scientific description
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.
Primary outcome measures
ULF-MRI sensitivity to detect presence of pathology
Time frame: Visit 1 and optional visit two within 180 days.
ULF-MRI sensitivity to detect presence of pathology in comparison to the standard field MRI measured in 100 cases. A study will be considered to have a positive finding if the clinical report from the MRI brain collected at standard field has an observation.
Technical development
Time frame: Visit 1 and optional repeated visits through the life of the protocol.
Optimization of acquisition parameters, reproducibility, and training of personnel.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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.
Where
- Bethesda, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations