Fast MR for Young Children With Traumatic Brain Injury

NCT ID: NCT02392975

Last Updated: 2019-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-02
• Study Completion Date: 2018-06-04

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.

Conditions

TBI (Traumatic Brain Injury)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fast MR

Intervention Type: PROCEDURE

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.

Computed Tomography

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Magnetic Resonance Imaging

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

• Maximum Eligible Age: 72 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David M Lindberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado School of Medicine

Aurora, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31533974 (View on PubMed)

Other Identifiers

14-1917

Identifier Type: -

Identifier Source: org_study_id