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MRE Evaluation for Spinal Cord Tumor Surgery: Stiffness and Adhesion Assessment

Primary Purpose

Spinal Cord Tumors

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Magnetic Resonance Elastography
Assessment and Recording
Sponsored by
Shengjing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Spinal Cord Tumors focused on measuring MRE, Slip Interface Imaging, Glioma, Magnetic Resonance Elastography, Spinal meningioma, Neurofibroma, Ependymoma, Astrocytoma, Glioblastoma, Spinal lipoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: All patients undergoing spinal cord tumor resection surgery are eligible for inclusion in the study cohort. Exclusion Criteria: Patients with metallic implants or foreign bodies in their bodies (pacemakers, artificial metallic heart valves, metal joints, metal implants, and those who cannot remove dentures, insulin pumps, or contraceptive rings) Pregnant women in the first trimester (within three months) Patients with severe claustrophobia or anxiety Patients with severe fever Patients who can not tolerate MRE Patients with vascular malformations and aneurysms. Patients who do not sign an informed consent

Sites / Locations

  • Shengjing HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic(MRE, tumor grading of stiffness and adhesion)

Arm Description

Patients undergo a preoperative routine MRI scan and MRE the day before their scheduled surgery. During surgery, the tumor stiffness and adhesion are assessed and recorded by the surgeon according to established evaluation criteria. It is important to note that the surgeon does not have prior knowledge of the tumor's specific stiffness and adhesion before the surgery. This information is typically obtained through intraoperative assessment and observation.

Outcomes

Primary Outcome Measures

Surgical assessment of tumor stiffness
The surgeon will score the tumor stiffness in seven aspects, ranging from 1 to 5 points: Tumor size; Shape of tumor; Tumor texture; Stiffness of the tumor's capsule; Stiffness of the tumor's central region; Primary methods of tumor removal; Features of tumor's capsule.
Surgical assessment of tumor adhesion
The surgeon will score the tumor's adhesion based on seven aspects, ranging from 1 to 4 points: Stripping instruments; Frequency of use of sharp instruments; Adhesion range; Degree of tumor resection; Cranial nerve anatomy preservation; Brain tissue anatomy preservation; Neurological function (compared with preoperative).

Secondary Outcome Measures

Full Information

First Posted
July 15, 2023
Last Updated
July 25, 2023
Sponsor
Shengjing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05957679
Brief Title
MRE Evaluation for Spinal Cord Tumor Surgery: Stiffness and Adhesion Assessment
Official Title
Preoperative Evaluation of Tumor Stiffness and Adhesion in Spinal Cord Tumor Using Magnetic Resonance Elastography
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shengjing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In spinal cord tumors requiring surgical intervention, the resection difficulty is determined by two significant factors: tumor stiffness and adhesion to surrounding tissue. The stiffness of the tumor dictates the complexity of removal, while strong adhesion presents additional challenges during the surgical procedure. This clinical trial aims to assess the clinical utility of magnetic resonance elastography (MRE), in evaluating the stiffness and adhesion of spinal cord tumors and guiding surgical planning to selecting the most appropriate surgical approach for patients with spinal cord tumors.
Detailed Description
Spinal cord tumors are a common condition in neurosurgery, including neurofibroma, spinal meningioma, ependymoma, glioma, spinal lipoma, and so on. Magnetic resonance imaging (MRI) plays a crucial role in the preoperative evaluation and planning of spinal cord tumor surgery. It provides detailed information about the tumor's location, size, and relationship to adjacent structures. However, routine MRI may not always provide sufficient information about the tumor's stiffness or adhesion, which can impact surgical planning and postoperative outcomes. Magnetic resonance elastography and slip interface imaging can help measure the mechanical properties of tissues, including their stiffness or adhesion. By combining the above methods, surgeons can identify areas of potential tumor adherence or invasion into surrounding structures, allowing for more precise surgical resection and minimizing the risk of damage to critical neural tissue.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Tumors
Keywords
MRE, Slip Interface Imaging, Glioma, Magnetic Resonance Elastography, Spinal meningioma, Neurofibroma, Ependymoma, Astrocytoma, Glioblastoma, Spinal lipoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic(MRE, tumor grading of stiffness and adhesion)
Arm Type
Experimental
Arm Description
Patients undergo a preoperative routine MRI scan and MRE the day before their scheduled surgery. During surgery, the tumor stiffness and adhesion are assessed and recorded by the surgeon according to established evaluation criteria. It is important to note that the surgeon does not have prior knowledge of the tumor's specific stiffness and adhesion before the surgery. This information is typically obtained through intraoperative assessment and observation.
Intervention Type
Diagnostic Test
Intervention Name(s)
Magnetic Resonance Elastography
Other Intervention Name(s)
MRE
Intervention Description
Undergo MRE and routine MRI
Intervention Type
Procedure
Intervention Name(s)
Assessment and Recording
Intervention Description
Undergo grading and recording of tumor stiffness and adhesion during surgery
Primary Outcome Measure Information:
Title
Surgical assessment of tumor stiffness
Description
The surgeon will score the tumor stiffness in seven aspects, ranging from 1 to 5 points: Tumor size; Shape of tumor; Tumor texture; Stiffness of the tumor's capsule; Stiffness of the tumor's central region; Primary methods of tumor removal; Features of tumor's capsule.
Time Frame
Baseline to 6 weeks
Title
Surgical assessment of tumor adhesion
Description
The surgeon will score the tumor's adhesion based on seven aspects, ranging from 1 to 4 points: Stripping instruments; Frequency of use of sharp instruments; Adhesion range; Degree of tumor resection; Cranial nerve anatomy preservation; Brain tissue anatomy preservation; Neurological function (compared with preoperative).
Time Frame
Baseline to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patients undergoing spinal cord tumor resection surgery are eligible for inclusion in the study cohort. Exclusion Criteria: Patients with metallic implants or foreign bodies in their bodies (pacemakers, artificial metallic heart valves, metal joints, metal implants, and those who cannot remove dentures, insulin pumps, or contraceptive rings) Pregnant women in the first trimester (within three months) Patients with severe claustrophobia or anxiety Patients with severe fever Patients who can not tolerate MRE Patients with vascular malformations and aneurysms. Patients who do not sign an informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Shi, MD
Phone
+86 189 4025 9980
Email
18940259980@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wen Cheng, MD
Phone
+86 150 4023 5535
Email
cmu071207@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Shi, MD
Organizational Affiliation
Shengjing Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anhua Wu, MD
Organizational Affiliation
Shengjing Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wen Cheng, MD
Organizational Affiliation
Shengjing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shengjing Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Shi, MD
Phone
+8618940259980
Email
18940259980@163.com
First Name & Middle Initial & Last Name & Degree
Anhua Wu, MD
Phone
+8618900925766
Email
wuanhua@yahoo.com
First Name & Middle Initial & Last Name & Degree
Yu Shi, MD
First Name & Middle Initial & Last Name & Degree
Anhua Wu, MD
First Name & Middle Initial & Last Name & Degree
Wen Cheng, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23082888
Citation
Murphy MC, Huston J 3rd, Glaser KJ, Manduca A, Meyer FB, Lanzino G, Morris JM, Felmlee JP, Ehman RL. Preoperative assessment of meningioma stiffness using magnetic resonance elastography. J Neurosurg. 2013 Mar;118(3):643-8. doi: 10.3171/2012.9.JNS12519. Epub 2012 Oct 19.
Results Reference
background
PubMed Identifier
26197204
Citation
Hughes JD, Fattahi N, Van Gompel J, Arani A, Meyer F, Lanzino G, Link MJ, Ehman R, Huston J. Higher-Resolution Magnetic Resonance Elastography in Meningiomas to Determine Intratumoral Consistency. Neurosurgery. 2015 Oct;77(4):653-8; discussion 658-9. doi: 10.1227/NEU.0000000000000892.
Results Reference
background
PubMed Identifier
33852045
Citation
Yin Z, Lu X, Cohen Cohen S, Sui Y, Manduca A, Van Gompel JJ, Ehman RL, Huston J 3rd. A new method for quantification and 3D visualization of brain tumor adhesion using slip interface imaging in patients with meningiomas. Eur Radiol. 2021 Aug;31(8):5554-5564. doi: 10.1007/s00330-021-07918-6. Epub 2021 Apr 14.
Results Reference
background
PubMed Identifier
28194925
Citation
Yin Z, Hughes JD, Trzasko JD, Glaser KJ, Manduca A, Van Gompel J, Link MJ, Romano A, Ehman RL, Huston J 3rd. Slip interface imaging based on MR-elastography preoperatively predicts meningioma-brain adhesion. J Magn Reson Imaging. 2017 Oct;46(4):1007-1016. doi: 10.1002/jmri.25623. Epub 2017 Feb 14. Erratum In: J Magn Reson Imaging. 2017 Dec;46(6):1851.
Results Reference
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MRE Evaluation for Spinal Cord Tumor Surgery: Stiffness and Adhesion Assessment

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