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OpenTrials
Recruiting

NCT Number: NCT04629469

Low Field and High Field Magnetic Resonance Imaging Assessments on Pediatric Patients

Hyperfine Research, Inc. has taken advantage of technological advances and developed an MRI device that is not only portable, but also uses a very-low magnetic field strength, [less than 0.2 Tesla or approximately 10 times less] than the field strength of conventional devices. This critical difference allows HRI to address MRI's core challenges by, first, operating at very low magnetic field strengths, eliminating the need for special rooms or shielding. Second, there are minimal safety concerns regarding ferrous metals near the system, as the field strength is too low to attract metal objects. The removal of metal, including items such as jewelry, belts, etc. from clothing and person, prior to being scanned, is unnecessary. Third, the design constraints faced by conventional MRI systems are lifted at low magnetic field and an open device has been designed to minimize anxiety that may come with claustrophobic patients. All of this is possible while still providing image quality that is clinically relevant to a wide variety of fields, including radiology, neurology, pediatrics, emergency medicine, and others.

Recruiting

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Key information

Age range

0 day–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inpatients at CMH Adele Hall ages 0 days to 22 years are eligible for enrollment.

Exclusion criteria

No additional sedation will be given as part of this study and that sedation, if already administered, will not be altered for study purposes.

Any patient who has a contraindication to having an MRI, such as:

Non-MRI conditional implanted device or device that is not able to be removed for MRI examination

Treatment and study plan

Hyperfine MRI

Diagnostic Test
  • Patients who have a standard of care MRI, CT or US will undergo a low-field MRI utilizing Hyperfine either at the patient's bedside or in the department of Radiology. Results of the Hyperfine MRI will not be used for clinical care and will only be available to members of the research team for review.

Primary outcomes

  1. Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US

    Time frame: Through study completion, an average of one year

    Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US

Study contacts

Contact information is provided by the study sponsor or research team.

Maura Sien, MS,RT(R)

CONTACT

[email protected]

8163028311

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Nov 16, 2020
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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