Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head UltrasoundNCT04629469
Low Field and High Field Magnetic Resonance Imaging Assessments on Pediatric Patients
A study testing Hyperfine MRI in people with Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head Ultrasound, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 days to 22 years
- Conditions the study is for
- Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head Ultrasound
- What is being tested?
- Hyperfine MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to Dec 2030
- Phase
- Interventional
- 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 0 days to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Inpatients at CMH Adele Hall ages 0 days to 22 years are eligible for enrollment.
Who cannot join
- 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
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
Children's Mercy Hospital
Kansas City, Missouri, 64108
Maura Sien, BS,RT(R), 8163026065, mesien@cmh.edu
Sarah Foster, 8162343273, ssfoster@cmh.edu
About this study
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.
- Being tested
- Hyperfine MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperfine MRIDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Hyperfine | Experimental | For patients that have standard of care head imaging, we will do a secondary analysis to compare their standard of care MRI, CT and/or US exams with Hyperfine MRI exams. Receives: Diagnostic Test: Hyperfine MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US
Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US
Measured: Through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Oct 2020
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head UltrasoundStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherwin Chan MD PhD, Children's Mercy Hospital Kansas City
- Investigators
- Sherwin Chan, MD,PHD, Principal investigator, Children's Mercy Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629469
- Sponsor's protocol ID
- STUDY00001356
- Status last verified
- Jan 2026
- First submitted
- 27 Oct 2020
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sien ME, Robinson AL, Hu HH, Nitkin CR, Hall AS, Files MG, Artz NS, Pitts JT, Chan SS. Feasibility of and experience using a portable MRI scanner in the neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed. 2023 Jan;108(1):45-50. doi: 10.1136/archdischild-2022-324200. Epub 2022 Jul 4.
PubMed 35788031
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Field and High Field Magnetic Resonance Imaging Assessments on Pediatric Patients
- ClinicalTrials.gov ID
- NCT04629469
- Acronym / sponsor ID
- STUDY00001356
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 16 Nov 2020 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperfine | Experimental | Diagnostic Test: Hyperfine MRIFor patients that have standard of care head imaging, we will do a secondary analysis to compare their standard of care MRI, CT and/or US exams with Hyperfine MRI exams. |
Who may qualify
- Ages
- 0 days to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Inpatients at CMH Adele Hall ages 0 days to 22 years are eligible for enrollment.
Key exclusion criteria (3 listed)
- No additional sedation will be given as part of this study and that sedation, if already administered, will not be altered for study purposes.
- Non-MRI conditional implanted device or device that is not able to be removed for MRI examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperfine MRI• 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. | Diagnostic test | Hyperfine |
Primary outcome
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
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 8 Jan 2026.
- Derived from this study: PubMed 35788031Sien ME, Robinson AL, Hu HH, Nitkin CR, Hall AS, Files MG, Artz NS, Pitts JT, Chan SS. Feasibility of and experience using a portable MRI scanner in the neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed. 2023 Jan;108(1):45-50. doi: 10.1136/archdischild-2022-324200. Epub 2022 Jul 4.
- Individual participant dataSharing planned: No
Related trials for Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head Ultrasound
Recruiting
Low Field Magnetic Resonance Imaging Assessment With Outpatients
Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head Ultrasound
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.
Sherwin Chan, MD,PHD principal investigator
Children's Mercy Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperfine MRI in people with Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head Ultrasound, run by Children's Mercy Hospital Kansas City 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 1 inclusion and 3 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 8 Jan 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 Maura Sien, MS,RT(R) (8163028311, mesien@cmh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US (time frame: Through study completion, an average of one year). 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 NCT04629469, which also lists 1 linked publication.
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 8 Jan 2026.