RECRUITING

Assessing and Improving Quantitative Magnetic Resonance Imaging Metrics in Human Subjects

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Assessing and Improving Quantitative Magnetic Resonance Imaging Metrics in Human Subjects

Quick Facts

Study Start:2023-02-02
Study Completion:2041-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05604534

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Stated willingness to comply with all study procedures and availability for the duration of the study
  2. * Male or female, aged 18 years of age and older
  3. * In good general health as evidenced by medical history
  4. * Ability of subject to understand and the willingness to sign a written informed consent document.
  5. * 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.
  1. * 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;
  2. * Has claustrophobia to a degree that would preclude lying comfortably in the scanner for the duration of the examination;
  3. * Cannot lie comfortably for up to 120 minutes;
  4. * Has hearing problems which would make it difficult to tolerate scanner noise;
  5. * 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.
  6. * Has medical health problems such as pulmonary or airway disease, heart failure, coronary artery disease, which would require physiological monitoring during the scan;
  7. * History of any medical condition that could result in an emergency medical situation while undergoing the MRI scan;
  8. * For \>7T: Has a ferromagnetic dental crown or a bridge.
  9. * 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.
  10. * Pregnant women:
  11. * a) If a woman is pregnant at the time of enrollment, we will popstpone enrollment until she is no longer pregnant.
  12. * Participants will not remain on the study should they have a positive pregnancy test at a study visit.

Contacts and Locations

Study Contact

Whitney M Spencer
CONTACT
(301) 402-6668
whitney.spencer@nih.gov
Carlo M Pierpaoli, M.D.
CONTACT
(301) 402-2289
carlo@helix.nih.gov

Principal Investigator

Carlo M Pierpaoli, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

  • Carlo M Pierpaoli, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Neurological Disorders and Stroke (NINDS)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-02
Study Completion Date2041-03-31

Study Record Updates

Study Start Date2023-02-02
Study Completion Date2041-03-31

Terms related to this study

Keywords Provided by Researchers

  • MRI
  • Healthy Adult
  • Diffusion
  • DTI
  • Diffusion Tensor Imaging
  • Natural History

Additional Relevant MeSH Terms

  • Normal Physiology