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Fast MR for Young Children With Traumatic Brain Injury

Primary Purpose

TBI (Traumatic Brain Injury)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fast MR
Computed Tomography
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for TBI (Traumatic Brain Injury)

Eligibility Criteria

undefined - 72 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fast magnetic resonance imaging (Fast MR)

Arm Description

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.

Outcomes

Primary Outcome Measures

Diagnostic utility (sensitivity/specificity) of fast MR to identify radiographic evidence of trauma as determined by dual, independent review by 2 masked pediatric neuroradiologists
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

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).
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)
Imaging time as determined by the time to complete all images - timer embedded in MR device

Full Information

First Posted
March 2, 2015
Last Updated
April 22, 2019
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT02392975
Brief Title
Fast MR for Young Children With Traumatic Brain Injury
Official Title
Fast MR for Young Children With Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 2, 2015 (Actual)
Primary Completion Date
June 4, 2018 (Actual)
Study Completion Date
June 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TBI (Traumatic Brain Injury)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
225 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fast magnetic resonance imaging (Fast MR)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Fast MR
Other Intervention Name(s)
Magnetic Resonance Imaging
Intervention Description
Enrolled subjects will undergo fast MR within 24 hours of CT completion. Subjects will be scanned using one of 2 Philips Ingenia MR 3T scanners. The estimated duration of the fast MR is less than 5 minutes, even if up to 2 sequences are repeated for motion.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Intervention Description
The Investigator will recruit children in whom a head CT is ordered as standard of care for TBI. Consenting subjects will undergo fast MR shortly after CT and results will be compared.
Primary Outcome Measure Information:
Title
Diagnostic utility (sensitivity/specificity) of fast MR to identify radiographic evidence of trauma as determined by dual, independent review by 2 masked pediatric neuroradiologists
Description
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).
Time Frame
0-15 minutes
Secondary Outcome Measure Information:
Title
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).
Time Frame
0-15 minutes
Title
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)
Time Frame
0-5 minutes
Title
Imaging time as determined by the time to complete all images - timer embedded in MR device
Time Frame
0-5 minutes

10. Eligibility

Sex
All
Maximum Age & Unit of Time
72 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Lindberg, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado School of Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31533974
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.
Results Reference
derived

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Fast MR for Young Children With Traumatic Brain Injury

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