Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 4:07 AM
Study NCT ID:
NCT02790294
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2016-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Timing of Postoperative Magnetic Resonance Imaging (MRI) in Patients With Extradural Spinal
Sponsor:
Case Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Optimal Timing of Postoperative Magnetic Resonance Imaging (MRI) in Patients With Extradural Spinal Tumors - a Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: