Optimal Timing of Postoperative Magnetic Resonance Imaging (MRI) in Patients With Extradural Spinal
Status: | Recruiting |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 19 - Any |
Updated: | 3/30/2019 |
Start Date: | January 25, 2016 |
End Date: | December 2019 |
Contact: | Lilyana Angelov, MD |
Email: | angelol@ccf.org |
Phone: | 216-444-4253 |
Optimal Timing of Postoperative Magnetic Resonance Imaging (MRI) in Patients With Extradural Spinal Tumors - a Pilot Study
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 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.
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.
Inclusion Criteria:
- Metastatic or primary malignant tumor involving spinal column, with or without
extension into the epidural space
- Operated for debulking, decompression or separation surgery;
- A magnetic resonance imaging (MRI) scan performed within 72 hours after surgery is
needed;
- Image quality acceptable for comparison with later MRI as read by a neuroradiologist;
- Karnofsky score of 60 or higher;
- Able to consent for the study.
Exclusion Criteria:
- Any patient who previously underwent spinal surgery at these levels will be excluded
to eliminate late postoperative changes.
- Intradural extension of the tumor.
- Patients, whose MRI at post operative 48-72 hours are not readable due to artifacts or
disease process shall not be included in the study.
- Patient not able to tolerate MRI scan due to claustrophobia or severe pain or allergic
reaction to contrast.
- Patients with an estimated Glomerular Filtration Rate (eGFR) < or = to 30 will be
excluded to avoid issues related to contrast administration in such patients. This
Glomerular Filtration Rate (GFR) threshold cutoff level is chosen per institutional
policy, because below that level other measures would be required (hydration or no
contrast administration). In order to keep the imaging information as uniform as
possible in such a small study group, patients with a low GFR will not be enrolled in
the study.
We found this trial at
1
site
Cleveland, Ohio 44195
Principal Investigator: Lilyana Angelov, MD
Phone: 216-444-4253
Click here to add this to my saved trials