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Recruiting NCT07577336

Portable MRI for Pediatric Hypoxic Ischemic Brain Injury

No phase Interventional Acute Brain Injury Hypoxia, Brain Ischemia, Brain Brain Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Portable MRI, Scavenged Sample Collection.
Who it may be relevant to
Registry conditions: Acute Brain Injury, Hypoxia, Brain, Ischemia, Brain, Brain Injuries. Basic parameters: up to 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Ultralow-Field Portable MRI for Detection of Pediatric Hypoxic Ischemic Brain Injury

Overview

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:

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Children's Mercy Hospital and Clinics — Kansas City

Identifiers

NCT: NCT07577336 · STUDY00003934

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗