Assessing and Improving Quantitative Magnetic Resonance Imaging Metrics in Human Subjects

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Observational

Phase

Not applicable / not listed

Age range

18 years - 100 years

Sex eligible

All sexes

Healthy volunteers

Accepted

Participants

200 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

Background:

Magnetic resonance imaging (MRI), which uses strong magnets to get images of structures inside the body, is a valuable tool in modern medicine. But researchers are always looking for ways to improve this technology. To better understand how to use MRI to diagnose problems, researchers need to collect more data from scans of healthy people.

Objective:

To get MRI scans of healthy people to improve the measurements doctors can make from the images.

Eligibility:

People aged 18 years or older in good general health.

Design:

Participants will be screened. They will have a physical exam focused on their nervous system. They will complete questionnaires.

Participants will have at least 1 MRI scan. The target of the scan may be the brain, liver, prostate, breast, or other body part. Before the scan, participants will remove any metallic objects. They will lie on a narrow table that moves into a long, narrow tube. They may have special pads placed around them to help them remain still.

Participants will hear loud noises during the scan. They will get earplugs or earmuffs to wear to muffle the sound. They can communicate with the MRI technician and will have an emergency button to squeeze at any time if they want the scan to stop. The scan will take up to 2 hours.

Some participants may be asked to perform tasks on a computer screen during the scan.

Participants may return for up to 5 scans in 3 months. Some may have as many as 30 MRI visits per year. They may remain in the study for up to 2 years.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean 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
• Male or female, aged 18 years of age and older
• In good general health as evidenced by medical history
• Ability of subject to understand and the willingness to sign a written informed consent document.
• Must have had a neurological physical exam as prescribed by NINDS policy. At the time of writing, this is required at least once every 2 years, and record of the exam should be in the medical record. This exam must be done prior to having MRI # 1. If deemed adequate by the Investigators, reports of examination by clinicians who are not Investigators on this study may be used. In addition, subjects must complete the most-recent version of the NMR safety screening form or NIH Radiology and IS MRI safety questionnaire when required at each visit.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

• Has any metal implant or objects of unknown identity or composition, or if it s known to be non-compatible with MRI, such as pacemakers, medication pumps, aneurysm clips, metallic prosthesis (such as heart valves or cochlear implants), certain orthopedic implants (pins and rods), shrapnel, or small metal fragments in the eye;
• Has claustrophobia to a degree that would preclude lying comfortably in the scanner for the duration of the examination;
• Cannot lie comfortably for up to 120 minutes;
• Has hearing problems which would make it difficult to tolerate scanner noise;
• Subjects with tattoos or permanent eye liner; liner; will not be excluded, however, tattoos carry a small risk of heating and burns. Therefore, each tattoo will be considered on a case by case basis, taking into account the age of the tattoo and the location of the tattoo on the subject s body.
• Has medical health problems such as pulmonary or airway disease, heart failure, coronary artery disease, which would require physiological monitoring during the scan;
• History of any medical condition that could result in an emergency medical situation while undergoing the MRI scan;
• For \>7T: Has a ferromagnetic dental crown or a bridge.
• Non-English speakers are excluded as it is important that volunteers understand the complex instructions required to undergo an MRI procedure, and there is no direct benefit to participants.
• Pregnant women:

• a) If a woman is pregnant at the time of enrollment, we will popstpone enrollment until she is no longer pregnant.
• Participants will not remain on the study should they have a positive pregnancy test at a study visit.

Study population

Adults 18 years of age or older, in good general health, who live in the DMV area.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Study start

Feb 2, 2023 Actual

Primary completion

Mar 31, 2041 Estimated

Study completion

Mar 31, 2041 Estimated

First posted

Nov 3, 2022 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts