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

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Seoul National University

Status

Completed

Conditions

Trauma

Treatments

Other: NC-MRI, CE-MRI

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01880944
B-1304-199-003

Details and patient eligibility

About

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.

Enrollment

300 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

ER-spine trauma
Description:
patients with spinal trauma, who initially visits in emergency room
Treatment:
Other: NC-MRI, CE-MRI
OUT-spine trauma
Description:
patients with spinal trauma, who initially visits in outpatient clinic
Treatment:
Other: NC-MRI, CE-MRI

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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