Clinical trial NCT06203626: Ultra-Low Field (ULF) Point-of-Care (POC) MRI System for Brain Morphology and Pathology
Official title: Ultra-Low Field (ULF) Point Of Care (POC) MRI System for Study Brain Morphology and Pathology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nervous System Diseases (C10 Unique ID D009422)
Keywords: MRI
Brain
Morphometry
ultra-low field MRI
Lesion
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2024-01-12
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers, Patients with previously identified brain anomalies, Patients with known or suspected neurological or neuro-oncological disorders, Stroke patients.

Brief 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.

Detailed description: Study Description:

Within the long-term goal of establishing a mobile research unit, this protocol aims at better understanding the utility and applicability of ULF MRI to deliver accessible neuroimages that could provide an opportunity for increasing participation in research, for early therapeutic intervention, and for potentially improvement of standard of care. For this purpose, we will invite healthy volunteers and populations with neurological presentations, mostly those enrolled in NIH studies collecting standard brain MRI, to participate in this protocol for ULF-MRI data collection. We will evaluate ULF MRI images in comparison to the standard field images. This analysis will aid at defining the type of research we can do with the ULF as a stand-alone technique and provide preliminary data for future research.

Based on the different clinical presentations, ancillary measures, such as cognitive, motor, and fatigue scales, optical coherence tomography, fundus, or blood samples, among others, might be collected to provide guidance for future studies.

Objectives:

Primary Objectives:

* Measure the ULF-MRI sensitivity to detect presence of pathology using the standard field MRI as the gold standard.
* To provide a framework for technical development.

Secondary Objective:

Describe participants social determinants of health.

Endpoints:

Primary Endpoint: ULF-MRI sensitivity to detect presence of pathology in comparison to the standard field MRI measured in 100 cases.

Secondary Endpoints: Descriptive participation.

Eligibility criteria: * 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.

Primary outcomes:
measure: ULF-MRI sensitivity to detect presence of pathology
timeFrame: Visit 1 and optional visit two within 180 days.
measure: Technical development
timeFrame: Visit 1 and optional repeated visits through the life of the protocol.
Secondary outcomes:
measure: Social determinants of health among participants
timeFrame: Visit 1.
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute of Neurological Disorders and Stroke (NINDS)
name: Silvina G Horovitz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: