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临床试验/NCT05957679
NCT05957679招募中不适用

Preoperative Evaluation of Tumor Stiffness and Adhesion in Spinal Cord Tumor Using Magnetic Resonance Elastography

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Surgical assessment of tumor stiffness

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients undergoing spinal cord tumor resection surgery are eligible for inclusion in the study cohort.

排除标准

  • 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

研究组 & 干预措施

Diagnostic(MRE, tumor grading of stiffness and adhesion)

Experimental

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.

干预措施: Magnetic Resonance Elastography (Diagnostic Test)

Diagnostic(MRE, tumor grading of stiffness and adhesion)

Experimental

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.

干预措施: Assessment and Recording (Procedure)

结局指标

主要结局

Surgical assessment of tumor stiffness

时间窗: 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

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu Shi

Deputy director of department of radology

Shengjing Hospital

研究点 (1)

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