TraumaNCT01880944
Evaluation of Usefulness of Contrast Enhanced MRI in Evaluation of Spine Trauma: Prospective Study
An observational study of Trauma, run by Seoul National University Bundang Hospital at 2 sites in South Korea.
Trial summary
Non-contrast MRI with T2 fat suppression has been a useful imaging modality in evaluation spinal trauma. However, the role of contrast enhancement has not investigated in patients with spinal trauma. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Trauma
- What is being tested?
- NC-MRI, CE-MRI
- How many people
- 300 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 24 Jun 2013to 14 Feb 2017
- How long will I take part?
- 2 Months
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 300 patients that fulfilled the following criteria
Who may be able to join
- Patients who provided the informed consent
- Patients with spinal trauma
- Patients with age of 19 years or more
Who cannot join
- Relative contraindication of MR contrast
- previous history of any adverse event after injection of magnetic resonance contrast
- pregnant or breast-feeding state
- within 2 weeks after liver transplantation
- epileptic disorder
- Patients impossible with follow-up period of at least 2 months clinically
- Patients with severely impaired renal function of estimated glomerular filtration rate (GFR) < 30 mL/min/1.73m2 and/or on dialysis
- patients with age less than 19 years
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Guen Young Lee
Seongnam-si, Gyenggi-do, 463-707
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 763-707
About this study
Non-contrast MRI with T2 fat suppression has been a useful imaging modality in evaluation spinal trauma.
However, the role of contrast enhancement has not investigated in patients with spinal trauma.
Therefore, this prospective study aims to evaluate the usefulness of contrast enhanced MRI for spinal trauma W/U clinically.
The study hypothesis is that there is no additional gain in addition of contrast enhanced study to routine non-contrast MRI.
- Conditions
- Trauma
- Being tested
- NC-MRI, CE-MRI
- Keywords
- spine, trauma, MRI, contrast
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NC-MRI, CE-MRIOther
Also called non-contrast spine MRI(NC-MRI), contrast-enhanced spine MRI(CE-MRI)
non-contrast spine MRI(NC-MRI) contrast-enhanced spine MRI(CE-MRI)
| Study group | Role | What they receive |
|---|---|---|
| ER-spine trauma | patients with spinal trauma, who initially visits in emergency room Receives: Other: NC-MRI, CE-MRI | |
| OUT-spine trauma | patients with spinal trauma, who initially visits in outpatient clinic Receives: Other: NC-MRI, CE-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate (%) of change of treatment option between non-surgery vs. surgery, after review of enhanced MRI finding, compared with non-enhanced MRI only
The rate (%) of change of treatment option between non-surgery vs. surgery, after review of enhanced MRI finding, compared with non-enhanced MRI only
Measured: 2 months
Confidence level
Confidence level (1, definitely negative; 2, probably negative; 3, equivocal; 4, probably positive; 5, definitely positive) for lesion of spinal body, posterior compartment, soft tissue (posterior ligamentous complex of thoracolumbar spine and discoligamentous complex of cervical spine), spinal cord, and epidural/subdural hematoma/hemorrhage
Measured: 2 months
Secondary outcomes (2)
Diagnostic accuracy of non-enhanced and enhanced MRI
Diagnostic accuracy of non-enhanced and enhanced MRI in patients with operations for each anatomical lesion (e.g. fracture of body, fracture of posterior compartment, soft tissue injury, cord injury, and epidural/subdural hematoma)
Measured: 2 months
Inter- and intra-reader agreement of confidence level
Inter- and intra-reader agreement of confidence level between non-enhanced and enhanced MRI
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study start24 Jun 2013
- Primary completion14 Dec 2016
- Study completion14 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Guen Young Lee, Seoul National University Bundang Hospital
- Investigators
- Guen Young Lee, MD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880944
- Sponsor's protocol ID
- B-1304-199-003
- Status last verified
- Oct 2018
- First submitted
- 14 Jun 2013
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Usefulness of Contrast Enhanced MRI in Evaluation of Spine Trauma: Prospective Study
- ClinicalTrials.gov ID
- NCT01880944
- Acronym / sponsor ID
- B-1304-199-003
- Conditions
- Trauma
- Keywords
- spine, trauma, MRI, contrast
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 24 Jun 2013 (actual)
- Primary completion
- 14 Dec 2016 (actual)
- Study completion
- 14 Feb 2017 (actual)
- First posted
- 19 Jun 2013 (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.
Non-contrast MRI with T2 fat suppression has been a useful imaging modality in evaluation spinal trauma.
However, the role of contrast enhancement has not investigated in patients with spinal trauma.
Therefore, this prospective study aims to evaluate the usefulness of contrast enhanced MRI for spinal trauma W/U clinically.
The study hypothesis is that there is no additional gain in addition of contrast enhanced study to routine non-contrast MRI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ER-spine trauma | – | Other: NC-MRI, CE-MRIpatients with spinal trauma, who initially visits in emergency room |
| OUT-spine trauma | – | Other: NC-MRI, CE-MRIpatients with spinal trauma, who initially visits in outpatient clinic |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 patients that fulfilled the following criteria
Key inclusion criteria (3 listed)
- Patients who provided the informed consent
- Patients with spinal trauma
- Patients with age of 19 years or more
Key exclusion criteria (8 listed)
- Relative contraindication of MR contrast
- Patients impossible with follow-up period of at least 2 months clinically
- Patients with severely impaired renal function of estimated glomerular filtration rate (GFR) < 30 mL/min/1.73m2 and/or on dialysis
- patients with age less than 19 years
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 |
|---|---|---|
| NC-MRI, CE-MRIAlso: non-contrast spine MRI(NC-MRI), contrast-enhanced spine MRI(CE-MRI)non-contrast spine MRI(NC-MRI) contrast-enhanced spine MRI(CE-MRI) | Other | ER-spine trauma, OUT-spine trauma |
Primary outcome
The rate (%) of change of treatment option between non-surgery vs. surgery, after review of enhanced MRI finding, compared with non-enhanced MRI only
Time frame: 2 months
The rate (%) of change of treatment option between non-surgery vs. surgery, after review of enhanced MRI finding, compared with non-enhanced MRI only
Confidence level
Time frame: 2 months
Confidence level (1, definitely negative; 2, probably negative; 3, equivocal; 4, probably positive; 5, definitely positive) for lesion of spinal body, posterior compartment, soft tissue (posterior ligamentous complex of thoracolumbar spine and discoligamentous complex of cervical spine), spinal cord, and epidural/subdural hematoma/hemorrhage
2 secondary outcomes
Diagnostic accuracy of non-enhanced and enhanced MRI
Time frame: 2 months
Inter- and intra-reader agreement of confidence level
Time frame: 2 months
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 5 Oct 2018.
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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.
Guen Young Lee, MD principal investigator
Seoul National University Bundang Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, run by Seoul National University Bundang Hospital at 2 sites in South Korea.
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 3 inclusion and 8 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 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
The rate (%) of change of treatment option between non-surgery vs. surgery, after review of enhanced MRI finding, compared with non-enhanced MRI only (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2018.