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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01880944
• Other study ID #: B-1304-199-003
• Status: Completed
• Start date: June 24, 2013
• Est. completion date: February 14, 2017

Study information

• Verified date: October 2018
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 14, 2017
• Est. primary completion date: December 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Trauma
• Wounds and Injuries

Intervention

Other:
• NC-MRI, CE-MRI
non-contrast spine MRI(NC-MRI) contrast-enhanced spine MRI(CE-MRI)

Locations

Country	Name	City	State
Korea, Republic of	Guen Young Lee	Seongnam-si	Gyenggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	Inter- and intra-reader agreement of confidence level	Inter- and intra-reader agreement of confidence level between non-enhanced and enhanced MRI	2 months