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

Not Applicable

Recruiting

• Conditions: Spinal Cord Tumors
• Interventions: Diagnostic Test: Magnetic Resonance Elastography; Procedure: Assessment and Recording

• Registration Number: NCT05957679
• Lead Sponsor: Shengjing Hospital

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.

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-15
• Study First Submitted QC: 2023-07-15
• Study First Posted: 2023-07-24
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27
• Primary Completion: 2024-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic（MRE, tumor grading of stiffness and adhesion）	Magnetic Resonance Elastography	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.
Diagnostic（MRE, tumor grading of stiffness and adhesion）	Assessment and Recording	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.

Primary Outcome Measures

Name	Time	Method
Surgical assessment of tumor stiffness	Baseline to 6 weeks	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	Baseline to 6 weeks	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).

Trial Locations

Locations (1)

Shengjing Hospital; 🇨🇳 Shenyang, Liaoning, China