Clinical trial NCT02790294: Optimal Timing of Postoperative Magnetic Resonance Imaging (MRI) in Patients With Extradural Spinal
Official title: Optimal Timing of Postoperative Magnetic Resonance Imaging (MRI) in Patients With Extradural Spinal Tumors - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Tumor
Keywords: magnetic resonance imaging
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 8
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients which have the same clinical decision from the immediate postoperative MRI and later imaging
timeFrame: Up to 3 weeks after surgery
Secondary outcomes:
measure: Change in tumor volume between immediate and later postoperative MRI
timeFrame: Up to 3 weeks after surgery
measure: Difference in level of discomfort as measured by a visual analog scale between postoperative MRIs
timeFrame: Up to 3 weeks after surgery
measure: Progression of tumor using RECIST Criteria
timeFrame: Up to 3 weeks after surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
name: Lilyana Angelov, MD
role: PRINCIPAL_INVESTIGATOR
References: