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Protocol Details

Ultra-Low Field (ULF) Point Of Care (POC) MRI System for Study Brain Morphology and Pathology

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

001719-N

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 3 Years
Max Age: 99 Years

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women

Keywords

MRI;
Brain;
Morphometry;
ultra-low field MRI;
Lesion

Recruitment Keyword(s)

None

Condition(s)

Nervous System Diseases (C10 Unique ID D009422)

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

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.

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Eligibility

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Silvina G. Horovitz, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7D37
10 Center Drive
Bethesda, Maryland 20892
(301) 435-2163
silvina.horovitz@nih.gov

Silvina G. Horovitz, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7D37
10 Center Drive
Bethesda, Maryland 20892
(301) 435-2163
silvina.horovitz@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937
ncimo_referrals@mail.nih.gov

Clinical Trials Number:

NCT06203626

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