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Trial Title:
MRE Evaluation for Spinal Cord Tumor Surgery: Stiffness and Adhesion Assessment
NCT ID:
NCT05957679
Condition:
Spinal Cord Tumors
Conditions: Official terms:
Spinal Cord Neoplasms
Conditions: Keywords:
MRE
Slip Interface Imaging
Glioma
Magnetic Resonance Elastography
Spinal meningioma
Neurofibroma
Ependymoma
Astrocytoma
Glioblastoma
Spinal lipoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Magnetic Resonance Elastography
Description:
Undergo MRE and routine MRI
Arm group label:
Diagnostic(MRE, tumor grading of stiffness and adhesion)
Other name:
MRE
Intervention type:
Procedure
Intervention name:
Assessment and Recording
Description:
Undergo grading and recording of tumor stiffness and adhesion during surgery
Arm group label:
Diagnostic(MRE, tumor grading of stiffness and adhesion)
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Shengjing Hospital
Address:
City:
Shenyang
Zip:
110000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Shi, MD
Phone:
+8618940259980
Email:
18940259980@163.com
Contact backup:
Last name:
Anhua Wu, MD
Phone:
+8618900925766
Email:
wuanhua@yahoo.com
Investigator:
Last name:
Yu Shi, MD
Email:
Principal Investigator
Investigator:
Last name:
Anhua Wu, MD
Email:
Principal Investigator
Investigator:
Last name:
Wen Cheng, MD
Email:
Principal Investigator
Start date:
January 1, 2023
Completion date:
September 1, 2026
Lead sponsor:
Agency:
Shengjing Hospital
Agency class:
Other
Source:
Shengjing Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05957679