Fast MR for Young Children With Traumatic Brain Injury

Not Applicable

Completed

• Conditions: TBI (Traumatic Brain Injury)
• Interventions: Procedure: Fast MR; Procedure: Computed Tomography

• Registration Number: NCT02392975
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-02
• Study First Submitted QC: 2015-03-18
• Study First Posted: 2015-03-19
• Study Start: 2015-06-02
• Primary Completion: 2018-06-04
• Study Completion: 2018-06-04
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-22
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fast magnetic resonance imaging (Fast MR)	Computed Tomography	All subjects will undergo fast MR in addition to Computerized Tomography (CT) (the current criterion standard). Fast MR will be interpreted independently for research purposes by 2 blinded radiologists. Consensus interpretation will be compared to the clinical reading of the CT.
Fast magnetic resonance imaging (Fast MR)	Fast MR	All subjects will undergo fast MR in addition to Computerized Tomography (CT) (the current criterion standard). Fast MR will be interpreted independently for research purposes by 2 blinded radiologists. Consensus interpretation will be compared to the clinical reading of the CT.

Primary Outcome Measures

Name	Time	Method
Diagnostic utility (sensitivity/specificity) of fast MR to identify radiographic evidence of trauma as determined by dual, independent review by 2 masked pediatric neuroradiologists	0-15 minutes	The main outcome measure will be the identification of radiographically apparent brain injury using cranial CT as the gold standard. Diagnostic utility (sensitivity/specificity) of fast MR to identify radiographic evidence of trauma (yes/no) as determined by dual, independent review by 2 masked pediatric neuroradiologists and compared to the clinical interpretation of CT (the current criterion standard).

Secondary Outcome Measures

Name	Time	Method
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)	0-5 minutes
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).	0-15 minutes
Imaging time as determined by the time to complete all images - timer embedded in MR device	0-5 minutes

Trial Locations

Locations (1)

University of Colorado School of Medicine; 🇺🇸 Aurora, Colorado, United States