Assessing and Improving Quantitative Magnetic Resonance Imaging Metrics in Human Subjects
- Conditions
- Normal Physiology
- Registration Number
- NCT05604534
- Brief Summary
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....
- Detailed Description
Study Description:
Biomarkers are of fundamental importance for any clinical endeavor aimed at improving human health. The main objective of this protocol is to discover and investigate quantitative metrics obtained with non-invasive imaging techniques, primarily MRI, that could become potential biomarkers of the anatomical and physiological state of living human tissues, and to improve the experimental design of MRI acquisitions to enable reliable measurement of these quantitative metrics.
Objectives:
We will develop and optimize novel quantitative MRI (qMRI) techniques on normal, healthy volunteers, and investigate the accuracy and reproducibility of these novel techniques across time and across different MRI scanners.
Primary Objective: To improve the experimental design of MRI acquisitions to enable reliable measurement of quantitative metrics that are candidate biomarkers in human subjects.
Secondary Objectives: To assess the relative contributions of true inter-individual biological differences and experimental noise to the overall variability of the measured qMRI metrics.
Endpoints:
Primary Endpoint: 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 metrics.
Secondary Endpoints: Extracting the contributions of experimental design and biological variability to overall variability.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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... The completion of data collection 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.
- Secondary Outcome Measures
Name Time Method Extracting the contributions of experimental design and biological variability to overall variability. The completion of data collection 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.
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States