Portable MRI for Pediatric Hypoxic Ischemic Brain Injury

Purpose

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
  • Trauma, Brain
  • Stroke

Eligibility

Eligible Ages
Under 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 - Active implants such as - Pacemaker - Implanted defibrillator - Implanted insulin pump - Deep brain stimulator - 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)
Masking Description
The neuroradiologists will be performing blinded assessments of the portable MRI images.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Portable MRI Arm 		All subjects enrolled with be assigned to Arm 1
  • Device: 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
  • Other: Scavenged Sample Collection
    Remaining blood or cerebrospinal fluid samples from clinical testing will be scavenged at timepoints correlating to the radiology imaging.

Recruiting Locations

Children's Mercy Hospital and Clinics
Kansas City, Missouri 64108
Contact:
Maura Sien, RT(R), CCRC
mesien@cmh.edu

More Details

Status
Recruiting
Sponsor
Children's Mercy Hospital Kansas City

Study Contact

Jessica S Wallisch, MD
(816) 234-3041
jwallisch@cmh.edu

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: 1. 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. 2. Minimizing conditions such as claustrophobia and anxiety with an open concept, transparent "helmet" to rest the head in during the exam. 3. Portable and can maneuver through hospital environments and wheeled directly to a patient's bedside. 4. 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.