Evaluation of Usefulness of Contrast Enhanced MRI in Evaluation of Spine Trauma: Prospective Study

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Usefulness of Contrast Enhanced MRI in Evaluation of Spine Trauma: Prospective Study

Conditions
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Trauma

Intervention / Treatment
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* Other: NC-MRI, CE-MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who provided the informed consent Patients with spinal trauma Patients with age of 19 years or more Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ER-spine trauma<br>patients with spinal trauma, who initially visits in emergency room | Other: NC-MRI, CE-MRI<br>* non-contrast spine MRI(NC-MRI) contrast-enhanced spine MRI(CE-MRI)<br>* Other names: contrast-enhanced spine MRI(CE-MRI);|
| OUT-spine trauma<br>patients with spinal trauma, who initially visits in outpatient clinic | Other: NC-MRI, CE-MRI<br>* non-contrast spine MRI(NC-MRI) contrast-enhanced spine MRI(CE-MRI)<br>* Other names: contrast-enhanced spine MRI(CE-MRI);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 2 months | 
| Inter- and intra-reader agreement of confidence level | Inter- and intra-reader agreement of confidence level between non-enhanced and enhanced MRI | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spine, trauma, MRI, contrast