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

Study Overview

• Status: Completed
• Conditions: Trauma
• Intervention / Treatment: Other: NC-MRI, CE-MRI

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyenggi-do
    • Seongnam-si, Gyenggi-do, Korea, Republic of, 463-707
      • Guen Young Lee
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 763-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

300 patients that fulfilled the following criteria

Description

Inclusion Criteria:

1. Patients who provided the informed consent
2. Patients with spinal trauma
3. Patients with age of 19 years or more

Exclusion Criteria:

1. 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
2. Patients impossible with follow-up period of at least 2 months clinically
3. Patients with severely impaired renal function of estimated glomerular filtration rate (GFR) < 30 mL/min/1.73m2 and/or on dialysis
4. patients with age less than 19 years

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ER-spine trauma; patients with spinal trauma, who initially visits in emergency room	Other: NC-MRI, CE-MRI; non-contrast spine MRI(NC-MRI) contrast-enhanced spine MRI(CE-MRI); Other Names: non-contrast spine MRI(NC-MRI); contrast-enhanced spine MRI(CE-MRI)
OUT-spine trauma; patients with spinal trauma, who initially visits in outpatient clinic	Other: NC-MRI, CE-MRI; non-contrast spine MRI(NC-MRI) contrast-enhanced spine MRI(CE-MRI); Other Names: non-contrast spine MRI(NC-MRI); contrast-enhanced spine MRI(CE-MRI)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prognostic value of enhanced MRI	Prognostic value of enhanced MRI, compared with non-enhanced MRI, based on clinical feature during follow-up period: TLICS(thoracolumbar injury classification and severity score) or SLIC(subaxial cervical injury classification system)score for non-surgery group vs. surgery group	2 months
The rate (%) of change of treatment plan	The rate (%) of change of treatment plan between posterior vs. anterior vs. anterior & posterior approaches, after review of enhanced MRI finding, compared with non-enhanced MRI only	2 months

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Collaborators: Bayer
• Investigators: Principal Investigator: Guen Young Lee, MD, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2013
• Primary Completion (Actual): December 14, 2016
• Study Completion (Actual): February 14, 2017

Study Registration Dates

• First Submitted: June 14, 2013
• First Submitted That Met QC Criteria: June 18, 2013
• First Posted (Estimate): June 19, 2013

Study Record Updates

• Last Update Posted (Actual): October 5, 2018
• Last Update Submitted That Met QC Criteria: October 3, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: MRI; trauma; spine; contrast
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: B-1304-199-003