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Completed

NCT Number: NCT01880944

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.

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Key information

Conditions

Trauma Wounds and Injuries

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guen Young Lee, Seongnam-si, Gyenggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NC-MRI, CE-MRI

Other

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)

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Diagnostic accuracy of non-enhanced and enhanced MRI

    Time frame: 2 months

    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. Inter- and intra-reader agreement of confidence level

    Time frame: 2 months

    Inter- and intra-reader agreement of confidence level between non-enhanced and enhanced MRI

Other outcomes

  1. Prognostic value of enhanced MRI

    Time frame: 2 months

    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. The rate (%) of change of treatment plan

    Time frame: 2 months

    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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • Bayer

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jun 19, 2013
Registry last updated
Oct 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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