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

NCT01880944 | Completed

• 1 other identifier: B-1304-199-003
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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. 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

Keywords

spine; trauma; MRI; contrast

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Diagnostic accuracy of non-enhanced and enhanced MRI

  2 months

• Inter- and intra-reader agreement of confidence level

  2 months

Other Outcomes (2)

• Prognostic value of enhanced MRI

  2 months

• The rate (%) of change of treatment plan

  2 months

Study Arms (2)

ER-spine trauma

patients with spinal trauma, who initially visits in emergency room

Other: NC-MRI, CE-MRI

OUT-spine trauma

patients with spinal trauma, who initially visits in outpatient clinic

Other: NC-MRI, CE-MRI

Interventions

NC-MRI, CE-MRI OTHER

non-contrast spine MRI(NC-MRI) contrast-enhanced spine MRI(CE-MRI)

Also known as: non-contrast spine MRI(NC-MRI), contrast-enhanced spine MRI(CE-MRI)

ER-spine trauma; OUT-spine trauma

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

300 patients that fulfilled the following criteria

You may qualify if:

• Patients who provided the informed consent
• Patients with spinal trauma
• Patients with age of 19 years or more

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• Bayer: collaborator

Study Sites (2)

Guen Young Lee

Seongnam-si, Gyenggi-do, 463-707, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 763-707, South Korea

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Guen Young Lee, MD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cinical assistant professor

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: June 19, 2013
• Study Start: June 24, 2013
• Primary Completion: December 14, 2016
• Study Completion: February 14, 2017
• Last Updated: October 5, 2018

Record last verified: 2018-10

Locations

KR (2)