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NCT02392975 · ClinicalTrials.gov registry record · NA

Fast MR for Young Children With Traumatic Brain Injury

A NA study, sponsored by University of Colorado, Denver.

Completed
Registry status
NA
Development phase
225
Enrollment target

NCT02392975: Completed NA study, sponsored by University of Colorado, Denver.

NCT02392975 is a NA study that has completed, run by University of Colorado, Denver. The registered enrollment target is 225 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02392975, a NA study, has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
NA
Development phase
225 participants
Enrollment target

Study 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.

Primary Outcome

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).

Interventions

  • PROCEDURE Computed Tomography
  • PROCEDURE Fast MR

Trial Details

FieldValue
Enrollment Target 225 participants
Start Date 2015-06-02
Est. Completion 2018-06-04
Phase NA
University of Colorado, Denver

1,283 total trials

What the finished NCT02392975 record still lists

NCT02392975 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).

The record links to 0 conditions, and to 2 interventions - of which Computed Tomography is the first listed.

NCT02392975 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02392975 about?

NCT02392975 is a clinical study titled "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 disa...

What is the current status of trial NCT02392975?

This trial is currently completed. It is a NA study. The enrollment target is 225 participants. The study started on 2015-06-02. Estimated completion is 2018-06-04.

What interventions are being tested in trial NCT02392975?

The interventions under investigation include: Computed Tomography (PROCEDURE), Fast MR (PROCEDURE).

Who is sponsoring clinical trial NCT02392975?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02392975's enrollment target sits among peer trials

225 472nd of 2000 higher than 1,523 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02392975, the US trial registry maintained by the National Library of Medicine. NCT02392975 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.