Clinical trial NCT02392975: Fast MR for Young Children With Traumatic Brain Injury
Official title: Fast MR for Young Children With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TBI (Traumatic Brain Injury)
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 225
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This proposal will test the diagnostic utility of fast magnetic resonance (MR) in young children with Traumatic brain Injury (TBI).

In children, TBI causes \>2000 deaths, 35,000 hospitalizations and 470,000 emergency department visits in the US each year, making it a leading cause of pediatric disability and death. Currently 20-50% of these children undergo computed tomography (CT) scanning, exposing them to harmful radiation, and increasing their lifetime risk of cancer. Risks are especially increased in children because the neurologic exam is less reliable, because growing tissues are more vulnerable to radiation, and because children have more years to accumulate harmful mutations.

Fast MR is a short, motion-tolerant protocol that has been used in children with shunted hydrocephalus to eliminate radiation exposure without the need for sedation. However, fast MR has not been validated in children with TBI, a critical gap. The investigators will measure feasibility and diagnostic utility of fast MR in children \< 6 years (72 months) old who undergo head CT for TBI.

The Investigator will recruit children in whom a head CT is ordered for TBI. Consenting subjects will undergo fast MR shortly after CT and results will be compared to determine: 1) whether fast MR identifies all traumatic injuries identified by CT and 2) whether fast MR without sedation can be performed quickly and successfully.


Eligibility criteria: Inclusion Criteria:

* Children \<72 months old in whom a head CT is ordered/obtained with concerns for TBI
* Present to the Children's Hospital Colorado (CHCO) Emergency Department (ED) or inpatient wards

Exclusion Criteria:

* Contraindication to MR (e.g. pacemaker, implanted metallic object incompatible with MR)
* Prior diagnosis of TBI, structural brain lesion or prior brain surgery including shunted hydrocephalus
* Prior participation in this study
* Clinically unstable in the opinion of the patient's attending physician
* Wards of the State
* TBI not included in the differential diagnosis of the patient's attending physician (e.g. the indication for imaging is concern for infections, tumor, autoimmune or inflammatory disease) or if imaging has already identified a non-traumatic source for symptoms

Primary outcomes:
measure: Diagnostic utility (sensitivity/specificity) of fast MR to identify radiographic evidence of trauma as determined by dual, independent review by 2 masked pediatric neuroradiologists
timeFrame: 0-15 minutes
Secondary outcomes:
measure: Accuracy of fast MR to determine type and location of injury as determined by dual, independent review by 2 masked pediatric neuroradiologists and compared to the clinical interpretation of CT (the current criterion standard).
timeFrame: 0-15 minutes
measure: Completion rate: determined by the number of fast MR's completed per protocol parameters (all sequences completed in <30 minutes; no request to stop imaging from physician, patient or family)
timeFrame: 0-5 minutes
measure: Imaging time as determined by the time to complete all images - timer embedded in MR device
timeFrame: 0-5 minutes
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: David M Lindberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lindberg DM, Stence NV, Grubenhoff JA, Lewis T, Mirsky DM, Miller AL, O'Neill BR, Grice K, Mourani PM, Runyan DK. Feasibility and Accuracy of Fast MRI Versus CT for Traumatic Brain Injury in Young Children. Pediatrics. 2019 Oct;144(4):e20190419. doi: 10.1542/peds.2019-0419.