TBI (Traumatic Brain Injury)NCT02392975
Fast MR for Young Children With Traumatic Brain Injury
A study testing Fast MR and Computed Tomography in people with TBI (Traumatic Brain Injury), run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 72 months
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- What is being tested?
- Fast MR and Computed Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2015to 4 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado School of Medicine
Aurora, Colorado, 80045
About this study
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.
Read more
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)
- Being tested
- Fast MR, Computed Tomography
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast MRProcedure or surgery
Also called Magnetic Resonance Imaging
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 TomographyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Fast magnetic resonance imaging (Fast MR) | Experimental | 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. Receives: Procedure: Fast MR; Procedure: Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 0-15 minutes
Secondary outcomes (3)
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).
Measured: 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)
Measured: 0-5 minutes
Imaging time as determined by the time to complete all images - timer embedded in MR device
Measured: 0-5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study start2 Jun 2015
- Primary completion4 Jun 2018
- Study completion4 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David M Lindberg, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392975
- Sponsor's protocol ID
- 14-1917
- Status last verified
- Apr 2019
- First submitted
- 2 Mar 2015
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31533974
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast MR for Young Children With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02392975
- Acronym / sponsor ID
- 14-1917
- Conditions
- TBI (Traumatic Brain Injury)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 2 Jun 2015 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fast magnetic resonance imaging (Fast MR) | Experimental | Procedure: Fast MR, Procedure: Computed TomographyAll 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. |
Who may qualify
- Ages
- Up to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast MRAlso: Magnetic Resonance ImagingEnrolled 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. | Procedure or surgery | Fast magnetic resonance imaging (Fast MR) |
| Computed TomographyThe 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. | Procedure or surgery | Fast magnetic resonance imaging (Fast MR) |
Primary outcome
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).
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Derived from this study: PubMed 31533974Lindberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M Lindberg, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast MR and Computed Tomography in people with TBI (Traumatic Brain Injury), run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02392975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.