Recruiting

pMRI

Sponsor:

Children's Mercy Hospital Kansas City

Code:

NCT07577336

Conditions

Acute Brain Injury

Hypoxia, Brain

Ischemia, Brain

Brain Injuries

Stroke

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Portable MRI

Scavenged Sample Collection

Study Details

Brief 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 modality following optimization of image acquisition. The results of this study will help determine optimal clinical implementation opportunities in pediatric patients.

Conditions

Acute Brain Injury

Hypoxia, Brain

Ischemia, Brain

Brain Injuries

Stroke

Study ID

NCT07577336

Start date

Jul 6, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Portable MRI Arm

All subjects enrolled with be assigned to Arm 1

Interventions

Portable MRI

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 Collection

Remaining blood or cerebrospinal fluid samples from clinical testing will be scavenged at timepoints correlating to the radiology imaging.

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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Jessica S Wallisch, MD

(816) 816-7929jwallisch@cmh.edu

Hannah Mendenhall, BSN, RN, CPN

816-816-9850hmendenhall@cmh.edu

Locations

Children's Mercy Kansas City

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Hannah Mendenhall, BSN, RN, CPN

816-816-9850hmendenhall@cmh.edu

Jessica Wallisch, MD

jwallisch@cmh.edu

More Information

Sponsor

Children's Mercy Hospital Kansas City

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Keywords

  • pediatric neurocritical care
  • neuroimaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Children's Mercy Hospital Kansas City on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.