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Trial record 94 of 959 for:    bone tumors AND NOT metastatic | Recruiting, Not yet recruiting, Available Studies

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
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.


Condition or disease Intervention/treatment Phase
Spinal Tumor Device: Magnetic Resonance Imaging Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Change in tumor volume between immediate and later postoperative MRI [ Time Frame: Up to 3 weeks after surgery ]
  2. Difference in level of discomfort as measured by a visual analog scale between postoperative MRIs [ Time Frame: Up to 3 weeks after surgery ]
  3. 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Lilyana Angelov, MD 216-444-4253 angelol@ccf.org
Contact: Wendi Evanoff 216-445-8797 evanofw@ccf.org

Locations
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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    angelol@ccf.org   
Contact: Wendi Evanoff    216-445-8797    evanofw@ccf.org   
Principal Investigator: Lilyana Angelov, MD         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Lilyana Angelov, MD Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02790294     History of Changes
Other Study ID Numbers: CASE4314
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Case Comprehensive Cancer Center:
magnetic resonance imaging

Additional relevant MeSH terms:
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Spinal Cord Neoplasms
Spinal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Bone Neoplasms
Bone Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Musculoskeletal Diseases
Spinal Diseases