Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head UltrasoundNCT05582785
Low Field Magnetic Resonance Imaging Assessment With Outpatients
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
The objective of the study is to perform imaging assessments of an early stage magnetic resonance imaging (MRI) system on patients using low field magnetic strength. Read more about this study
- Who is it for?
- Ages 0 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
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 31 Dec 2026
- 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 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Outpatients at CMH Adele Hall Radiology 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 Kansas City
Kansas City, Missouri, 64108
Maura Sien, 8163026065, mesien@cmh.edu
Amie Robinson, 8163028311, alrobinson@cmh.edu
About this study
The objective of the study is to perform imaging assessments of an early stage magnetic resonance imaging (MRI) system on patients using low field magnetic strength.
- 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 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 500 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582785
- Sponsor's protocol ID
- STUDY00002266
- Status last verified
- Feb 2026
- First submitted
- 8 Sep 2022
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Field Magnetic Resonance Imaging Assessment With Outpatients
- ClinicalTrials.gov ID
- NCT05582785
- Acronym / sponsor ID
- STUDY00002266
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Oct 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.
The objective of the study is to perform imaging assessments of an early stage magnetic resonance imaging (MRI) system on patients using low field magnetic strength.
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 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Outpatients at CMH Adele Hall Radiology 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 MRIPatients 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 3 years
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 6 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head Ultrasound
Recruiting
Low Field and High Field Magnetic Resonance Imaging Assessments on Pediatric Patients
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
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 6 Feb 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) (8163026065, 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 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2026.