NCT02790294

Optimal Timing of Postoperative Magnetic Resonance Imaging (MRI) in Patients With Extradural Spinal

Optimal Timing of Postoperative Magnetic Resonance Imaging (MRI) in Patients With Extradural Spinal Tumors - a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating suitability of a delayed magnetic resonance imaging (MRI) in management of spine tumors. Currently the standard of care is obtaining an MRI scan in the early postoperative period (within 72 hours after surgery). The purpose of this study is to see if delayed MRI (2 to 3 weeks after surgery) is similar in quality to the earlier MRI. In this study patients will undergo 2 MRIs after the surgery instead of one MRI. Patients will have one MRI about 3 days after the surgery and one MRI about 2-3 weeks after surgery.

Detailed description

Primary aim: Assess if Magnetic Resonance Imaging (MRI) at 2 to 3 weeks after surgery leads to the same clinical decisions and has the same probability of being chosen by a physician for guiding the subsequent management of the patient, compared with immediately postoperative MRI. Secondary aims: Investigate the differences between early and late MRI by comparing: * Size of tumor in three dimensions; * Extent of edema; * Presence and extent of fluid collection; * Spine Oncology Study Group score; * Involvement of adjacent levels; * Progression of tumor; * Patient's preference/performance scale right after each image had taken: level of discomfort at around the time each MRI was performed. Study Design: This is a prospective diagnostic study for which no standard of care currently exists.

Conditions

• Spinal Tumor

Interventions

Type	Name	Description
DEVICE	Magnetic Resonance Imaging	The routine spine MRI protocol will be utilized, which includes the following sequences: haste localizer, sagittal T1, T2, and short-T1 Inversion Recovery (STIR), axial T2 for lumbar spine or axial gradient echo for cervical and thoracic spine, axial T1, post contrast sagittal and axial T1. All scans will be obtained using a 1.5 Tesla magnet.

Timeline

• Start date: 2016-08-31
• Primary completion: 2020-12-17
• Completion: 2020-12-17
• First posted: 2016-06-03
• Last updated: 2024-05-14

Locations

1 site across 1 country: United States