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

NCT ID: NCT02790294

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2020-12-17

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.

Conditions

Spinal Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Postoperative Magnetic Resonance Imaging

Three MRIs will be performed. One at baseline, one within 72 hours postoperative, and one 2-3 weeks postoperative.

Group Type: EXPERIMENTAL

Magnetic Resonance Imaging

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

MRI

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lilyana Angelov, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CASE4314

Identifier Type: -

Identifier Source: org_study_id