Assessing and Improving Quantitative Magnetic Resonance Imaging Metrics in Human Subjects

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

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

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Healthy Adult

Trial outcomes

Primary outcomes

1

Assessing the reproducibility of metrics derived from quantitative MRI data, evaluating the effects of acquisition modalities, such as experimental design, and choice of acquisition sequences and hardware, on the overall variability of these met...

For a given qMRI metric (e.g. mean diffusivity, T1, T2) under investigation and a given organ (e.g. brain, peripheral nerve, prostate) under investigation: 1) Map values of the metric under investigation throughout the organ 2) Measure the variability of the measured values in repeated scans on one MRI scanner 3) Measure the variability of the measured values acquired using proposed improvements in experimental design and document that a proposed improvement (e.g., improved pulse sequence acquisition, post processing technique) results in improved reproducibility.

Time frame
The completion of data collection

Secondary outcomes

1

Extracting the contributions of experimental design and biological variability to overall variability.

1\) Extract the contributions of experimental noise to the overall variability through repeated scans in individual subjects 2) Using the experimental noise measurements from step 1, analyze differences across the study subject population to extract the true inter-individual biological differences.

Time frame
The completion of data collection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute of Neurological Disorders and Stroke (NINDS)

Lead sponsor

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator