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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):

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.


Condition or disease Intervention/treatment
TBI (Traumatic Brain Injury) Procedure: Fast MR Procedure: Computed Tomography

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Fast MR for Young Children With Traumatic Brain Injury
Study Start Date : April 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
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.


Outcome Measures

Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Imaging time as determined by the time to complete all images - timer embedded in MR device [ Time Frame: 0-5 minutes ]

Eligibility Criteria

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Ages Eligible for Study:   up to 72 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02392975


Contacts
Contact: Daniel M Lindberg, MD 720-848-6765 daniel.lindberg@ucdenver.edu
Contact: Kathleen Grice, BS 303-724-3285 kathleen.grice@childrenscolorado.org

Locations
United States, Colorado
Recruiting
Denver, Colorado, United States
Contact: Kathleen Grice    303-724-3285    kathleen.grice@childrenscolorado.org   
Sponsors and Collaborators
University of Colorado, Denver
More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02392975     History of Changes
Other Study ID Numbers: 14-1917
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System