Optimal Timing of Postoperative Magnetic Resonance Imaging (MRI) in Patients With Extradural Spinal
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|ClinicalTrials.gov Identifier: NCT02790294|
Recruitment Status : Recruiting
First Posted : June 3, 2016
Last Update Posted : December 6, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Tumor||Device: Magnetic Resonance Imaging||Not Applicable|
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.
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.
This is a prospective diagnostic study for which no standard of care currently exists.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimal Timing of Postoperative Magnetic Resonance Imaging (MRI) in Patients With Extradural Spinal Tumors - a Pilot Study|
|Actual Study Start Date :||January 25, 2016|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||May 2019|
Experimental: Postoperative Magnetic Resonance Imaging
Three MRIs will be performed. One at baseline, one within 72 hours postoperative, and one 2-3 weeks postoperative.
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.
Other Name: MRI
- Number of patients which have the same clinical decision from the immediate postoperative MRI and later imaging [ Time Frame: Up to 3 weeks after surgery ]Assess if Magnetic Resonance Imaging (MRI) at 2 to 3 weeks after surgery (aka: later imaging) 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 (within 72 hours, aka: early imaging).
- Change in tumor volume between immediate and later postoperative MRI [ Time Frame: Up to 3 weeks after surgery ]
- Difference in level of discomfort as measured by a visual analog scale between postoperative MRIs [ Time Frame: Up to 3 weeks after surgery ]
- Progression of tumor using RECIST Criteria [ Time Frame: Up to 3 weeks after surgery ]RECIST response categories: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790294
|Contact: Lilyana Angelov, MDfirstname.lastname@example.org|
|Contact: Wendi Evanoffemail@example.com|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Lilyana Angelov, MD 216-444-4253 firstname.lastname@example.org|
|Contact: Wendi Evanoff 216-445-8797 email@example.com|
|Principal Investigator: Lilyana Angelov, MD|
|Principal Investigator:||Lilyana Angelov, MD||Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center|