- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03291964
Rapid MRI for Acute Pediatric Head Trauma
April 25, 2022 updated by: Dr. David Sheridan, Oregon Health and Science University
QuickBrain MRI for Acute Pediatric Head Trauma
Pediatric head trauma is a leading cause of morbidity and mortality for children/adolescents.
The current standard of care regarding imaging modality when concerned for an acute head injury is CT.
This exposes children to radiation that may predispose to future malignancy.
Rapid MRI is a test that eliminates radiation and has expanded uses in multiple other areas.
This study is evaluating it for pediatric acute head trauma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Initial retrospective study suggests that QbMRI has adequate sensitivity to detect acute ciTBIs in children.
This preliminary study included all pediatric trauma patients presenting to OHSU from 2/2010 through 12/2013 who had both a head CT and QbMRI.
The current standard of care in the pediatric ICU at OHSU is for patients admitted with an acute head injury to undergo routine QbMRI follow up to assess status of the injury rather than a repeat head CT.
Our study team collected clinical data on these patients that included clinical interventions and then de-identified all head CT and QbMRI images for this cohort.
The images were then independently reviewed by 2 neuroradiology fellows at OHSU (Please refer to Figure 1).
The sensitivity of QbMRI to detect any radiographic injury was 85% (95% CI: 73, 93), but increased when evaluating clinically important TBIs to 100% (95% CI: 89, 100).
The largest limitation of this study was the variable and often long time interval between acquisition of the head CT and QbMRI.
The average length of time between the initial head CT and QbMRI was 27.5 hours with only 41% receiving both imaging tests within 12 hours of each other.
Also, preliminary data was collected by retrospective review.
As such, it is very promising that initial study had high sensitivity, but further prospective pilot data with a shorter interval between the index and reference test is needed to assess the discrepancy between the two types of lesions (radiographic vs clinically important) and feasibility of obtaining qbMRI in the setting of acute pediatric head trauma.
While this study did not miss any clinically important TBIs, on further review of radiographic "missed lesions", the study pediatric neurosurgeon noted signs of a healing bleed.
This may suggest that they were "missed" because they were healed rather than present and not seen.
All patients that did not have a lesion identified on QbMRI did not require significant clinical interventions and only underwent periods of observation in the hospital.
However, this raises the need for a prospective trial to obtain QbMRI imaging within the same time frame sequentially after the initial head CT.
Study Type
Observational
Enrollment (Actual)
76
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- OHSU
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second to 14 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All pediatric trauma patients being evaluated with a head CT for acute intracranial injury
Description
Inclusion Criteria:
- The patient presents to the pediatric emergency department or trauma system at OHSU or is a trauma system transfer patient to OHSU
- Age 0-14 years.
- Being evaluated for a traumatic head injury and attending physician decides to obtain a head CT.
- Clinically stable for additional testing: provider deems it safe to obtain a QbMRI in the ED without deep sedation
Exclusion Criteria:
- Subject is from outside hospital and head CT was performed greater than 6 hours prior
- Subject is from outside hospital and initial head CT is not in our imaging system for review
- History of intracranial surgery
- History of metallic implants making MRI contraindicated
- Decompressive surgery prior to QbMRI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity: Percentage of MRIs Correctly Identifying Clinically Important Intracranial Injury (True Positives)
Time Frame: within 6 hours from the initial head CT
|
Sensitivity of Rapid MRI for detection of a clinically important intracranial injury: Percentage of MRIs identifying clinically important intracranial injury.
Sensitivity was calculated as the number of true positives divided by "true positive plus false negative".
True positive was defined based on meeting clinical criteria for a clinically important TBI and if the imaging found the injury.
|
within 6 hours from the initial head CT
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time From Order to Obtaining MRI
Time Frame: During initial ER stay within 3 hours from time of entry to the ER
|
minutes
|
During initial ER stay within 3 hours from time of entry to the ER
|
Need for Anxiolysis Medication (Defined as Benzodiazepines for Imaging Indication)
Time Frame: During initial ER stay within 3 hours from time of entry to the ER
|
Number of patients requiring medication to obtain imaging
|
During initial ER stay within 3 hours from time of entry to the ER
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: David Sheridan, MD MCR, Oregon Health and Science University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 3, 2017
Primary Completion (Actual)
August 1, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
June 27, 2017
First Submitted That Met QC Criteria
September 21, 2017
First Posted (Actual)
September 25, 2017
Study Record Updates
Last Update Posted (Estimate)
January 26, 2023
Last Update Submitted That Met QC Criteria
April 25, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17254
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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