Children's Mercy Hospital and Clinics
Kansas City, Missouri, 64108, United States
Location status: Recruiting
NCT Number: NCT07577336
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.
Interested in participating?
Request InfoUp to 17 year
All sexes
Interventional
Not applicable
Kansas City, Missouri, 64108, United States
Location status: Recruiting
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: During intensive care admittance, an average of 1 month
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
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
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.
Contact information is provided by the study sponsor or research team.
Allison Scott, RN, CCRC
CONTACT
Jessica S Wallisch, MD
CONTACT
Children's Mercy Hospital Kansas City
Other
Ultralow-Field Portable MRI for Detection of Pediatric Hypoxic Ischemic Brain Injury
Acronym: pMRI for pHIBI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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