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

Primary Purpose

Spinal Tumor

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Magnetic Resonance Imaging

About this trial

This is an interventional diagnostic trial for Spinal Tumor focused on measuring magnetic resonance imaging

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Postoperative Magnetic Resonance Imaging

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change in tumor volume between immediate and later postoperative MRI

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

Progression of tumor using RECIST Criteria

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.

Full Information

NCT ID

NCT02790294

First Posted

May 31, 2016

Last Updated

May 4, 2021

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT02790294

Brief Title

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

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

August 31, 2016 (Actual)

Primary Completion Date

December 17, 2020 (Actual)

Study Completion Date

December 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Tumor

Keywords

magnetic resonance imaging

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Postoperative Magnetic Resonance Imaging

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Magnetic Resonance Imaging

Other Intervention Name(s)

MRI

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Up to 3 weeks after surgery

Secondary Outcome Measure Information:

Title

Change in tumor volume between immediate and later postoperative MRI

Time Frame

Up to 3 weeks after surgery

Title

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

Time Frame

Up to 3 weeks after surgery

Title

Progression of tumor using RECIST Criteria

Description

Time Frame

Up to 3 weeks after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lilyana Angelov, MD

Organizational Affiliation

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

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

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