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

NCT02790294 | Completed

• 1 other identifier: CASE4314
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Tumor

Keywords

magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Number of patients which have the same clinical decision from the immediate postoperative MRI and later imaging

  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).

  Up to 3 weeks after surgery

Secondary Outcomes (3)

• Change in tumor volume between immediate and later postoperative MRI

  Up to 3 weeks after surgery

• Difference in level of discomfort as measured by a visual analog scale between postoperative MRIs

  Up to 3 weeks after surgery

• Progression of tumor using RECIST Criteria

  Up to 3 weeks after surgery

Study Arms (1)

Postoperative Magnetic Resonance Imaging

EXPERIMENTAL

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

Device: Magnetic Resonance Imaging

Interventions

Magnetic Resonance Imaging 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.

Also known as: MRI

Postoperative Magnetic Resonance Imaging

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Spinal Cord Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Lilyana Angelov, MD

  Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 3, 2016
• Study Start: August 31, 2016
• Primary Completion: December 17, 2020
• Study Completion: December 17, 2020
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

US (1)