Acute Brain InjurypMRI for HIBINCT07577336
Portable MRI for Pediatric Hypoxic Ischemic Brain Injury
A study testing Portable MRI and Scavenged Sample Collection in people with Acute Brain Injury and Hypoxia, Brain, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
This study will evaluate the sensitivity and specificity of low field portable MRI (pMRI) for detection of hypoxic ischemic brain injuries in pediatric patients compared to clinically obtained neuroimaging to define pediatric diagnostic limitations and to determine the diagnostic capabilities of this neuroimaging… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Acute Brain Injury, Hypoxia, Brain, Ischemia, Brain
- What is being tested?
- Portable MRI and Scavenged Sample Collection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2026to Dec 2027
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients hospitalized in the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit
- Ages 0-17 years at study enrollment
- Acute neurologic deficit suspected secondary to Hypoxic Ischemic Brain Injury (HIBI) or patients at high risk for HIBI
Who cannot join
- Pregnancy
- Any patient who has a contraindication to having an MRI
- Patients with a passive or active implant will:
- First be reviewed on MRISafety.com to determine MR conditionality
- If the device is listed as Conditional or Unsafe for a 1.5T or a 3T, the device will then be reviewed by the MRI Safety Officer or MRI Physician Section chief to determine true conditionality for the portable MRI
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
Hannah Mendenhall, BSN, RN, CPN, 816-816-9850, hmendenhall@cmh.edu
Jessica Wallisch, MD, jwallisch@cmh.edu
About this study
Official title: Ultralow-Field Portable MRI for Detection of Pediatric Hypoxic Ischemic Brain Injury
This study will evaluate the sensitivity and specificity of low field portable MRI (pMRI) for detection of hypoxic ischemic brain injuries in pediatric patients compared to clinically obtained neuroimaging to define pediatric diagnostic limitations and to determine the diagnostic capabilities of this neuroimaging modality following optimization of image acquisition. The results of this study will help determine optimal clinical implementation opportunities in pediatric patients.
Read the detailed description
Standard brain magnetic resonance imaging (MRI) is the gold-standard to diagnose acute ischemic brain injuries; however, it is not always feasible to obtain this standard MRI due to risks and contraindications. Some of the most common risks can include transport to the radiology department, especially with critically ill patients on life-saving medical devices, exposure to ionizing radiation, and contraindications can include incompatible surgical hardware in patients' bodies, amongst others.
Our institution has an FDA-cleared portable MRI (pMRI) by Hyperfine Research, Inc. (HRI). This device addresses many of the conventional MRI challenges by:
- Operating at very low magnetic field strengths strength (less than 0.2 T or approximately 10 times less than the field strength of conventional devices) and eliminating the need for special rooms or shielding. Family members and staff can remain at the patient's bedside.
- Minimizing conditions such as claustrophobia and anxiety with an open concept, transparent "helmet" to rest the head in during the exam.
- Portable and can maneuver through hospital environments and wheeled directly to a patient's bedside.
- Noise levels are substantially lower than conventional MRI systems, so hearing protection is optional for the patient. The sounds are described as vibrations that produce rhythmic tones.
- Conditions
- Acute Brain Injury, Hypoxia, Brain, Ischemia, Brain, Brain Injuries, Stroke
- Being tested
- Portable MRI, Scavenged Sample Collection
- Keywords
- pediatric neurocritical care, neuroimaging
- Medical subject headings
- Brain Injuries, Hypoxia, Brain, Brain Ischemia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable MRIDevice
Enrolled subjects will undergo a portable, ultralow-field MRI (pMRI) at the bedside in the ICU location within +/- 24 hours of a clinically obtained, conventional MRI and/or head CT
Scavenged Sample CollectionOther
Remaining blood or cerebrospinal fluid samples from clinical testing will be scavenged at timepoints correlating to the radiology imaging.
| Study group | Role | What they receive |
|---|---|---|
| Portable MRI Arm | Experimental | All subjects enrolled with be assigned to Arm 1 Receives: Device: Portable MRI; Other: Scavenged Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the sensitivity and specificity of pMRI for detection of acute pediatric focal ischemic brain injuries.
Perform pMRI on pediatric ICU patients within +/- 24 hours of a clinically obtained, conventional MRI. Compare detection rates and severity of ischemia and cerebral edema by pMRI vs conventional MRI to determine sensitivity and specificity.
Measured: During intensive care admittance, an average of 1 month
Establish the sensitivity and specificity of pMRI relative to head CT for detection of cerebral edema and ischemic brain injury in critically ill patients deemed unstable for standard MRI.
Perform pMRI on pediatric ICU patients within +/- 24 hours of a clinically obtained, conventional head CT obtained for acute neurologic changes. Compare detection rates and severity of cerebral edema and ischemia by pMRI vs head CT to establish sensitivity and specificity.
Measured: During intensive care admittance, an average of 1 month
Calculate the sensitivity and specificity of pMRI for detection of acute pediatric global hypoxic-ischemic brain injuries
Perform pMRI on pediatric ICU patients within +/- 24 hours of a clinically obtained, conventional MRI that demonstrates acute global hypoxic-ischemic brain injury as read by a clinical neuroradiologist. Compare detection rates and severity of acute global hypoxic-ischemic brain injury by pMRI vs conventional MRI to calculate sensitivity and specificity.
Measured: During intensive care admittance, an average of 1 month
Secondary outcomes (1)
Assess the association of imaging findings and rates of clinical neurologic events
The rate of seizures, pupillary changes, focal neurologic deficits, and other clinical neuromonitoring data will be assessed for correlation to and type of acute brain injury diagnosed on neuroimaging.
Measured: From ICU admission until final neuroimaging during active study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start6 Jul 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Brain InjuryStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica S. Wallisch, Children's Mercy Hospital Kansas City
- Investigators
- Jessica S Wallisch, MD, Principal investigator, Children's Mercy Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577336
- Sponsor's protocol ID
- STUDY00003934
- Acronym
- pMRI for HIBI
- Status last verified
- Sep 2026
- First submitted
- 3 May 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data, images, and biosamples will be stored in an institutional Pediatric Acute Brain Injury (PediABI) Repository. De-identified IPD will be made available upon reasonable request to the study PI with appropriate IRB approval and contracting.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultralow-Field Portable MRI for Detection of Pediatric Hypoxic Ischemic Brain Injury
- ClinicalTrials.gov ID
- NCT07577336
- Acronym / sponsor ID
- pMRI for HIBI / STUDY00003934
- Conditions
- Acute Brain Injury, Hypoxia, Brain, Ischemia, Brain, Brain Injuries, Stroke
- Keywords
- pediatric neurocritical care, neuroimaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 May 2026 (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.
This study will evaluate the sensitivity and specificity of low field portable MRI (pMRI) for detection of hypoxic ischemic brain injuries in pediatric patients compared to clinically obtained neuroimaging to define pediatric diagnostic limitations and to determine the diagnostic capabilities of this neuroimaging modality following optimization of image acquisition. The results of this study will help determine optimal clinical implementation opportunities in pediatric patients.
Detailed description
Standard brain magnetic resonance imaging (MRI) is the gold-standard to diagnose acute ischemic brain injuries; however, it is not always feasible to obtain this standard MRI due to risks and contraindications. Some of the most common risks can include transport to the radiology department, especially with critically ill patients on life-saving medical devices, exposure to ionizing radiation, and contraindications can include incompatible surgical hardware in patients' bodies, amongst others.
Our institution has an FDA-cleared portable MRI (pMRI) by Hyperfine Research, Inc. (HRI). This device addresses many of the conventional MRI challenges by:
- Operating at very low magnetic field strengths strength (less than 0.2 T or approximately 10 times less than the field strength of conventional devices) and eliminating the need for special rooms or shielding. Family members and staff can remain at the patient's bedside.
- Minimizing conditions such as claustrophobia and anxiety with an open concept, transparent "helmet" to rest the head in during the exam.
- Portable and can maneuver through hospital environments and wheeled directly to a patient's bedside.
- Noise levels are substantially lower than conventional MRI systems, so hearing protection is optional for the patient. The sounds are described as vibrations that produce rhythmic tones.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Portable MRI Arm | Experimental | Device: Portable MRI, Other: Scavenged Sample CollectionAll subjects enrolled with be assigned to Arm 1 |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients hospitalized in the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit
- Ages 0-17 years at study enrollment
- Acute neurologic deficit suspected secondary to Hypoxic Ischemic Brain Injury (HIBI) or patients at high risk for HIBI
Key exclusion criteria (5 listed)
- Pregnancy
- Any patient who has a contraindication to having an MRI
- First be reviewed on MRISafety.com to determine MR conditionality
- If the device is listed as Conditional or Unsafe for a 1.5T or a 3T, the device will then be reviewed by the MRI Safety Officer or MRI Physician Section chief to determine true conditionality for the portable MRI
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 |
|---|---|---|
| Portable MRIEnrolled subjects will undergo a portable, ultralow-field MRI (pMRI) at the bedside in the ICU location within +/- 24 hours of a clinically obtained, conventional MRI and/or head CT | Device | Portable MRI Arm |
| Scavenged Sample CollectionRemaining blood or cerebrospinal fluid samples from clinical testing will be scavenged at timepoints correlating to the radiology imaging. | Other | Portable MRI Arm |
Primary outcome
Determine the sensitivity and specificity of pMRI for detection of acute pediatric focal ischemic brain injuries.
Time frame: During intensive care admittance, an average of 1 month
Perform pMRI on pediatric ICU patients within +/- 24 hours of a clinically obtained, conventional MRI. Compare detection rates and severity of ischemia and cerebral edema by pMRI vs conventional MRI to determine sensitivity and specificity.
Establish the sensitivity and specificity of pMRI relative to head CT for detection of cerebral edema and ischemic brain injury in critically ill patients deemed unstable for standard MRI.
Time frame: During intensive care admittance, an average of 1 month
Perform pMRI on pediatric ICU patients within +/- 24 hours of a clinically obtained, conventional head CT obtained for acute neurologic changes. Compare detection rates and severity of cerebral edema and ischemia by pMRI vs head CT to establish sensitivity and specificity.
Calculate the sensitivity and specificity of pMRI for detection of acute pediatric global hypoxic-ischemic brain injuries
Time frame: During intensive care admittance, an average of 1 month
Perform pMRI on pediatric ICU patients within +/- 24 hours of a clinically obtained, conventional MRI that demonstrates acute global hypoxic-ischemic brain injury as read by a clinical neuroradiologist. Compare detection rates and severity of acute global hypoxic-ischemic brain injury by pMRI vs conventional MRI to calculate sensitivity and specificity.
1 secondary outcome
Assess the association of imaging findings and rates of clinical neurologic events
Time frame: From ICU admission until final neuroimaging during active study participation
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 24 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data, images, and biosamples will be stored in an institutional Pediatric Acute Brain Injury (PediABI) Repository. De-identified IPD will be made available upon reasonable request to the study PI with appropriate IRB approval and contracting.
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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.
Jessica S Wallisch, MD 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 Portable MRI and Scavenged Sample Collection in people with Acute Brain Injury and Hypoxia, Brain, 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 3 inclusion and 5 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 24 Sep 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 Jessica S Wallisch, MD ((816) 816-7929, jwallisch@cmh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the sensitivity and specificity of pMRI for detection of acute pediatric focal ischemic brain injuries. (time frame: During intensive care admittance, an average of 1 month). The study lists 3 primary outcomes in all. 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 24 Sep 2026.