Normal PhysiologyNCT05604534
Assessing and Improving Quantitative Magnetic Resonance Imaging Metrics in Human Subjects
An observational study of Normal Physiology, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Physiology
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2023to 31 Mar 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults 18 years of age or older, in good general health, who live in the DMV area.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Normal Physiology
- Keywords
- MRI, Healthy Adult, Diffusion, DTI, Diffusion Tensor Imaging, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adult | Adults 18 years of age or older, in good general health |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The completion of data collection
Secondary outcomes (1)
Extracting the contributions of experimental design and biological variability to overall variability.
- 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.
Measured: The completion of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start2 Feb 2023
- Primary completion31 Mar 2041 (estimated)
- Study completion31 Mar 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Normal PhysiologyStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- Carlo M Pierpaoli, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604534
- Sponsor's protocol ID
- 10000784
- Other IDs
- 000784-N
- Status last verified
- 30 Sep 2026
- First submitted
- 2 Nov 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We do plan to share IPD. we will share all IPD that results in a publication on a public repository, as required by most journals. the data will be de-identified and anonymized.
Publications
Walker L, Curry M, Nayak A, Lange N, Pierpaoli C; Brain Development Cooperative Group. A framework for the analysis of phantom data in multicenter diffusion tensor imaging studies. Hum Brain Mapp. 2013 Oct;34(10):2439-54. doi: 10.1002/hbm.22081. Epub 2012 Mar 28.
PubMed 22461391Sadeghi N, Nayak A, Walker L, Okan Irfanoglu M, Albert PS, Pierpaoli C; Brain Development Cooperative Group. Analysis of the contribution of experimental bias, experimental noise, and inter-subject biological variability on the assessment of developmental trajectories in diffusion MRI studies of the brain. Neuroimage. 2015 Apr 1;109:480-92. doi: 10.1016/j.neuroimage.2014.12.084. Epub 2015 Jan 9.
PubMed 25583609Pierpaoli C. Quantitative brain MRI. Top Magn Reson Imaging. 2010 Apr;21(2):63. doi: 10.1097/RMR.0b013e31821e56f8. No abstract available.
PubMed 21613871
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing and Improving Quantitative Magnetic Resonance Imaging Metrics in Human Subjects
- ClinicalTrials.gov ID
- NCT05604534
- Acronym / sponsor ID
- 10000784
- Conditions
- Normal Physiology
- Keywords
- MRI, Healthy Adult, Diffusion, DTI, Diffusion Tensor Imaging, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 31 Mar 2041 (estimated)
- Study completion
- 31 Mar 2041 (estimated)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adult | – | –Adults 18 years of age or older, in good general health |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults 18 years of age or older, in good general health, who live in the DMV area.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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...
Time frame: 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.
1 secondary outcome
Extracting the contributions of experimental design and biological variability to overall variability.
Time frame: The completion of data collection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 22461391Walker L, Curry M, Nayak A, Lange N, Pierpaoli C; Brain Development Cooperative Group. A framework for the analysis of phantom data in multicenter diffusion tensor imaging studies. Hum Brain Mapp. 2013 Oct;34(10):2439-54. doi: 10.1002/hbm.22081. Epub 2012 Mar 28.
- Background: PubMed 25583609Sadeghi N, Nayak A, Walker L, Okan Irfanoglu M, Albert PS, Pierpaoli C; Brain Development Cooperative Group. Analysis of the contribution of experimental bias, experimental noise, and inter-subject biological variability on the assessment of developmental trajectories in diffusion MRI studies of the brain. Neuroimage. 2015 Apr 1;109:480-92. doi: 10.1016/j.neuroimage.2014.12.084. Epub 2015 Jan 9.
- Background: PubMed 21613871Pierpaoli C. Quantitative brain MRI. Top Magn Reson Imaging. 2010 Apr;21(2):63. doi: 10.1097/RMR.0b013e31821e56f8. No abstract available.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We do plan to share IPD. we will share all IPD that results in a publication on a public repository, as required by most journals. the data will be de-identified and anonymized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlo M Pierpaoli, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Physiology, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Whitney M Spencer ((301) 402-6668, whitney.spencer@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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... (time frame: The completion of data collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05604534, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.