TBI (Traumatic Brain Injury) Clinical Trial
Official title:
Fast MR for Young Children With Traumatic Brain Injury
NCT number | NCT02392975 |
Other study ID # | 14-1917 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2, 2015 |
Est. completion date | June 4, 2018 |
Verified date | April 2019 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 225 |
Est. completion date | June 4, 2018 |
Est. primary completion date | June 4, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 72 Months |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado School of Medicine | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | 0-15 minutes | |
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | Imaging time as determined by the time to complete all images - timer embedded in MR device | 0-5 minutes |
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