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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Seoul National University Bundang Hospital
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Guen Young Lee, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01880944
First received: June 14, 2013
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Trauma
Other: NC-MRI, CE-MRI

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: Evaluation of Usefulness of Contrast Enhanced MRI in Evaluation of Spine Trauma: Prospective Study

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Diagnostic accuracy of non-enhanced and enhanced MRI [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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)

  • Inter- and intra-reader agreement of confidence level [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Inter- and intra-reader agreement of confidence level between non-enhanced and enhanced MRI


Other Outcome Measures:
  • Prognostic value of enhanced MRI [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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

  • The rate (%) of change of treatment plan [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 300
Study Start Date: June 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

300 patients that fulfilled the following criteria

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01880944

Contacts
Contact: Guen Young Lee, MD 82-31-787-7630 netty0523@gmail.com
Contact: Joon Woo Lee, MD, PhD 82-31-787-7616 joonwoo2@gmail.com

Locations
Korea, Republic of
Guen Young Lee Recruiting
Seongnam-si, Gyenggi-do, Korea, Republic of, 463-707
Contact: Guen Young Lee, MD    82-31-787-7630    netty0523@gmail.com   
Contact: Joon Woo Lee, MD    82-31-787-7616    joonwoo2@gmail.com   
Seoul National University Bundang Hospital Not yet recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 763-707
Contact: Guen Young Lee, MD    82-31-787-7630    netty0523@gmail.com   
Principal Investigator: Guen Young Lee, MD         
Sponsors and Collaborators
Seoul National University Bundang Hospital
Bayer
Investigators
Principal Investigator: Guen Young Lee, MD Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Guen Young Lee, Cinical assistant professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01880944     History of Changes
Other Study ID Numbers: B-1304-199-003
Study First Received: June 14, 2013
Last Updated: July 1, 2013
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by Seoul National University Bundang Hospital:
spine
trauma
MRI
contrast

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on September 14, 2014