An interventional study of Portable MRI and Scavenged Sample Collection in Acute Brain Injury, Hypoxia, Brain and Ischemia, Brain, sponsored by Children's Mercy Hospital Kansas City. Recruiting at 1 site in United States. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Children's Mercy Hospital Kansas City · Not applicable, Interventional, and Diagnostic
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.
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:
946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.
This study's planned enrollment of 200 is above the median of 41 across 612 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Children's Mercy Hospital Kansas City is the lead sponsor of 210 studies on the registry; 20 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with a passive or active implant will:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All subjects enrolled with be assigned to Arm 1
Device: Portable MRI · Other: Scavenged Sample Collection
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
Remaining blood or cerebrospinal fluid samples from clinical testing will be scavenged at timepoints correlating to the radiology imaging.
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.
Time frame: 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.
Time frame: 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.
Time frame: During intensive care admittance, an average of 1 month
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.
Time frame: From ICU admission until final neuroimaging during active study participation
Plan to share: 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.
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Dec 2027, 17 months after the start.
Of 284 non-industry interventional studies with no phase under Brain Injuries, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 17 months is below that.
Counting every sponsor, half of 297 studies reached it within 24 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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