Feasibility and Safety of a Low-field MRINCT06074406
Low-Field Bedside Brain Magnetic Resonance Imaging in Pediatric Extracorporeal Membrane Oxygenation
A study testing Hyperfine in people with Feasibility and Safety of a Low-field MRI and Acute Brain Injury, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The primary object of the study is to further characterize safety and feasibility of low-field bedside MRI in pediatric and neonatal ECMO patients. 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 Up to 17 years
- Conditions the study is for
- Feasibility and Safety of a Low-field MRI, Acute Brain Injury, Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- Hyperfine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subjects admitted to the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit at Children's Mercy Kansas City
- Ages 0-17 years
- Undergoing venovenous or venoarterial ECMO
Who cannot join
- Pregnancy
- Active implants such as:
- Pacemaker
- Implanted defibrillator
- Implanted insulin pump
- Deep brain stimulator
Show all 15Show fewer
- Vagus nerve stimulator
- Cochlear implant
- Programmable shunt
- MRI incompatible surgical hardware (e.g., staples, screws, etc.)
- Metal-containing tattoos or permanent make-up on head or neck
- Suspected metal in eye, e.g.,
- Former or current welders, metal workers, or individuals with a metal injury
- Metal shrapnel
- Passive implants are considered MRI conditional
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Kansas City
Kansas City, Missouri, 64108
About this study
Official title: Low-Field Bedside Magnetic Resonance Imaging for Detection of Acute Brain Injury in Pediatric Extracorporeal Membrane Oxygenation
The primary object of the study is to further characterize safety and feasibility of low-field bedside MRI in pediatric and neonatal ECMO patients. To perform imaging assessments of an early-stage magnetic resonance imaging (MRI) system on patients using low field magnetic strength. Collect qualitative data from the image assessments to optimize device performance using a low field magnetic resonance imaging device in a simulated use environment; Collect qualitative data from the image assessments using a high field magnetic resonance imaging, computed tomography and ultrasound devices. Generate anonymized image data for post-acquisition evaluation, performance measuring and planning for subsequent study size
- Conditions
- Feasibility and Safety of a Low-field MRI, Acute Brain Injury, Extracorporeal Membrane Oxygenation Complication
- Being tested
- Hyperfine
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperfineDevice
Enrolled subjects will undergo a Hyperfine MRI exam, which is a portable, low-field MRI, at various timepoints during their clinical course on ECMO
| Study group | Role | What they receive |
|---|---|---|
| Portable MRI Arm | Experimental | All subjects enrolled with be assigned to Arm 1 Receives: Device: Hyperfine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examining the occurrence of adverse events and serious adverse events with portable MRI use in ECMO patients
Measuring the occurrence of adverse events and serious adverse events that occurring during the portable MRI procedure. Adverse events and serious adverse events include (change in mean arterial pressure by 20% increase or decreased measured by the meters of mercury as identified by catheter measurement in patient, a decrease in the ECMO flow rate by 20% measured in milliliters per min by the ECMO machine, decrease in the oxygen saturation by 10% measured by pulse oximetry, dislodgement of the ECMO cannula measured by the occurrence of hemorrhage, as identified by PI).
Measured: During Intervention, and immediately after intervention.
Assessing the time needed to conduct a portable MRI with ECMO patients.
The analyses will examine the amount of time it takes to conduct a Portable MRI with ECMO patients. The examination records the amount of time to prep and move the patient to the portable MRI and back from the portable MRI. Preparation and movement of patient will be measured using a stopwatch identifying the number of minuets passed. The amount of time it takes to conduct the portable MRI with ECMO patients will also be analyzed. The time the MRI takes will be measured using a stopwatch examining the number of minuets passed.
Measured: Pre intervention during patient prep, and during intervention, and immediately intervention.
Analyzing the number of staff required to conduct a Portable MRI with an ECMO patient.
The analysis will examine the number of staff needed to prep and use a portable MRI with patients. Number of staff needed will be record in RedCap via head count.
Measured: Pre intervention, during intervention, and immediately after intervention.
Determine the number of critical care therapies conducted during imaging studies.
Analyzing the number of critical therapies conducted during patient prep, during intervention, and post intervention. The study will record in RedCap the number of critical care therapies identified by study coordinator and PI by counting the number of therapies. Critical care therapies include (EEG, mechanical ventilation, continuous renal replacement therapy, continuous IV infusions, temporary pacing wires).
Measured: Pre intervention during patient prep, during intervention, and immediately after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start30 Aug 2023
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
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 Feasibility and Safety of a Low-field MRIStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
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 Wallisch, MD, Principal investigator, Children's Mercy Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074406
- Sponsor's protocol ID
- STUDY00002824
- Status last verified
- Jan 2026
- First submitted
- 4 Sep 2023
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wallisch JS, Wagner AF, Daniel JM, Taber A, Sien M, Foster S, Artz N, Zinkus TP, Yeh HW, Pineda JA, Kochanek PM, Chan SS. Ultra-Low-Field Portable Magnetic Resonance Imaging Feasibility and Safety in Pediatric and Neonatal Extracorporeal Membrane Oxygenation: A Single-Center Year-Long Experience. J Am Heart Assoc. 2025 Nov 18;14(22):e043434. doi: 10.1161/JAHA.125.043434. Epub 2025 Nov 11.
PubMed 41220148
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
- Low-Field Bedside Magnetic Resonance Imaging for Detection of Acute Brain Injury in Pediatric Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT06074406
- Acronym / sponsor ID
- STUDY00002824
- Conditions
- Feasibility and Safety of a Low-field MRI, Acute Brain Injury, Extracorporeal Membrane Oxygenation Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 10 Oct 2023 (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 primary object of the study is to further characterize safety and feasibility of low-field bedside MRI in pediatric and neonatal ECMO patients. To perform imaging assessments of an early-stage magnetic resonance imaging (MRI) system on patients using low field magnetic strength. Collect qualitative data from the image assessments to optimize device performance using a low field magnetic resonance imaging device in a simulated use environment; Collect qualitative data from the image assessments using a high field magnetic resonance imaging, computed tomography and ultrasound devices. Generate anonymized image data for post-acquisition evaluation, performance measuring and planning for subsequent study size
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Portable MRI Arm | Experimental | Device: HyperfineAll 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)
- Subjects admitted to the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit at Children's Mercy Kansas City
- Ages 0-17 years
- Undergoing venovenous or venoarterial ECMO
Key exclusion criteria (15 listed)
- Pregnancy
- Active implants such as:
- MRI incompatible surgical hardware (e.g., staples, screws, etc.)
- Metal-containing tattoos or permanent make-up on head or neck
- Suspected metal in eye, e.g.,
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 |
|---|---|---|
| HyperfineEnrolled subjects will undergo a Hyperfine MRI exam, which is a portable, low-field MRI, at various timepoints during their clinical course on ECMO | Device | Portable MRI Arm |
Primary outcome
Examining the occurrence of adverse events and serious adverse events with portable MRI use in ECMO patients
Time frame: During Intervention, and immediately after intervention.
Measuring the occurrence of adverse events and serious adverse events that occurring during the portable MRI procedure. Adverse events and serious adverse events include (change in mean arterial pressure by 20% increase or decreased measured by the meters of mercury as identified by catheter measurement in patient, a decrease in the ECMO flow rate by 20% measured in milliliters per min by the ECMO machine, decrease in the oxygen saturation by 10% measured by pulse oximetry, dislodgement of the ECMO cannula measured by the occurrence of hemorrhage, as identified by PI).
Assessing the time needed to conduct a portable MRI with ECMO patients.
Time frame: Pre intervention during patient prep, and during intervention, and immediately intervention.
The analyses will examine the amount of time it takes to conduct a Portable MRI with ECMO patients. The examination records the amount of time to prep and move the patient to the portable MRI and back from the portable MRI. Preparation and movement of patient will be measured using a stopwatch identifying the number of minuets passed. The amount of time it takes to conduct the portable MRI with ECMO patients will also be analyzed. The time the MRI takes will be measured using a stopwatch examining the number of minuets passed.
Analyzing the number of staff required to conduct a Portable MRI with an ECMO patient.
Time frame: Pre intervention, during intervention, and immediately after intervention.
The analysis will examine the number of staff needed to prep and use a portable MRI with patients. Number of staff needed will be record in RedCap via head count.
Determine the number of critical care therapies conducted during imaging studies.
Time frame: Pre intervention during patient prep, during intervention, and immediately after intervention.
Analyzing the number of critical therapies conducted during patient prep, during intervention, and post intervention. The study will record in RedCap the number of critical care therapies identified by study coordinator and PI by counting the number of therapies. Critical care therapies include (EEG, mechanical ventilation, continuous renal replacement therapy, continuous IV infusions, temporary pacing wires).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Results publication: PubMed 41220148Wallisch JS, Wagner AF, Daniel JM, Taber A, Sien M, Foster S, Artz N, Zinkus TP, Yeh HW, Pineda JA, Kochanek PM, Chan SS. Ultra-Low-Field Portable Magnetic Resonance Imaging Feasibility and Safety in Pediatric and Neonatal Extracorporeal Membrane Oxygenation: A Single-Center Year-Long Experience. J Am Heart Assoc. 2025 Nov 18;14(22):e043434. doi: 10.1161/JAHA.125.043434. Epub 2025 Nov 11.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Jessica 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 Hyperfine in people with Feasibility and Safety of a Low-field MRI and Acute Brain Injury, 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 15 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examining the occurrence of adverse events and serious adverse events with portable MRI use in ECMO patients (time frame: During Intervention, and immediately after intervention.). The study lists 4 primary outcomes in all. 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 NCT06074406, 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 24 Sep 2026.