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临床试验/NCT06955208
NCT06955208招募中不适用

Evaluation of Meningioma Mechanical Properties and Histological Features Using Three-Dimensional Magnetic Resonance Elastography

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年10月19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
300
试验地点
1
主要终点
Agreement Between MRE Stiffness and Intraoperative Tumor Consistency

研究概览

简要总结

This prospective single-center study aims to evaluate the feasibility and clinical utility of three-dimensional magnetic resonance elastography (3D MRE) in assessing tumor stiffness and adhesion in patients with meningioma undergoing surgical resection. By correlating preoperative MRE-derived stiffness and adhesion maps with intraoperative findings and histopathological features, the study seeks to determine whether MRE can serve as a noninvasive imaging biomarker for surgical planning, risk stratification, and prediction of tumor behavior.

详细描述

Meningiomas are the most common primary intracranial tumors and are often surgically resectable. However, the intraoperative texture and adhesion of the tumor to surrounding structures vary widely and directly impact the surgical approach, difficulty, and outcomes. Current preoperative imaging lacks the ability to quantitatively assess biomechanical properties such as stiffness and adhesion, which are critical for neurosurgical planning.

This prospective clinical trial investigates the application of 3D magnetic resonance elastography (MRE) in characterizing the biomechanical properties of meningiomas. Specifically, it aims to quantify tumor stiffness and adhesion using MRE-derived shear modulus maps and correlate these measurements with intraoperative surgeon-assessed stiffness/adhesion scores and postoperative histopathology. The study will also assess the diagnostic performance of MRE in predicting challenging resections, high tumor adhesion, and histological subtypes.

Approximately 300 patients with radiologically confirmed meningioma scheduled for elective resection will be enrolled. Participants will undergo standard MRI and additional 3D MRE scanning. Intraoperative findings including tumor stiffness, adhesion, blood supply, and resection difficulty will be systematically recorded. Postoperative pathological analysis will include tumor grade and histological subtype. Statistical analyses will evaluate correlations, diagnostic accuracy, and potential prognostic value.

Findings from this study may support the use of 3D MRE as a valuable noninvasive tool in preoperative assessment of meningiomas, helping optimize surgical strategies, reduce complications, and inform treatment decisions.

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
是

入选标准

  • •All patients undergoing meningeoma 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 can not 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

MRE-Guided Surgery Group

Experimental

Participants in this group will undergo preoperative three-dimensional magnetic resonance elastography (3D MRE) in addition to routine MRI. MRE will be used to quantify tumor stiffness and generate a three-dimensional adhesion map. These imaging findings will be provided to the neurosurgical team prior to surgery to assist in planning the surgical approach and anticipating tumor consistency and adhesiveness. Intraoperative outcomes such as resection time, blood loss, and dissection difficulty will be recorded and analyzed in relation to preoperative MRE parameters.

干预措施: Magnetic Resonance Elastography (Diagnostic Test)

MRE-Guided Surgery Group

Experimental

Participants in this group will undergo preoperative three-dimensional magnetic resonance elastography (3D MRE) in addition to routine MRI. MRE will be used to quantify tumor stiffness and generate a three-dimensional adhesion map. These imaging findings will be provided to the neurosurgical team prior to surgery to assist in planning the surgical approach and anticipating tumor consistency and adhesiveness. Intraoperative outcomes such as resection time, blood loss, and dissection difficulty will be recorded and analyzed in relation to preoperative MRE parameters.

干预措施: Intraoperative Assessment and Recording (Procedure)

结局指标

主要结局

Agreement Between MRE Stiffness and Intraoperative Tumor Consistency

时间窗: Intraoperative (Day of Surgery)

The primary outcome is the correlation between preoperative 3D MRE-derived shear stiffness values and intraoperative tumor consistency as assessed by the neurosurgeon using a standardized ordinal scale (1-5). Agreement will be evaluated using Spearman correlation and Bland-Altman analysis.

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

Professor

Shengjing Hospital

研究点 (1)

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