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Fast MR for Young Children With Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT02392975
Recruitment Status : Recruiting
First Posted : March 19, 2015
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):

March 2, 2015
March 19, 2015
January 17, 2018
April 2015
October 2018   (Final data collection date for primary outcome 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 [ Time Frame: 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).
Diagnostic utility (sensitivity/specificity) of fast MR to identify radiographic evidence of trauma as determined by dual, independent review by 2 masked pediatric neuroradiologists [ Time Frame: 0-5 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).
Complete list of historical versions of study NCT02392975 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Imaging time as determined by the time to complete all images - timer embedded in MR device [ Time Frame: 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). [ Time Frame: 0-5 minutes ]
  • 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 ]
  • Imaging time as determined by the time to complete all images - timer embedded in MR device [ Time Frame: 0-5 minutes ]
Not Provided
Not Provided
 
Fast MR for Young Children With Traumatic Brain Injury
Fast MR for Young Children With Traumatic Brain Injury

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
TBI (Traumatic Brain Injury)
  • Procedure: Fast MR
    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.
    Other Name: Magnetic Resonance Imaging
  • Procedure: Computed Tomography
    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.
Experimental: Fast magnetic resonance imaging (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.
Interventions:
  • Procedure: Fast MR
  • Procedure: Computed Tomography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
November 2018
October 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 72 Months   (Child)
No
Contact: Daniel M Lindberg, MD 720-848-6765 daniel.lindberg@ucdenver.edu
Contact: Kathleen Grice, BS 303-724-3285 kathleen.grice@childrenscolorado.org
United States
 
 
NCT02392975
14-1917
No
Not Provided
Not Provided
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Not Provided
University of Colorado, Denver
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP