Magnetic Resonance Elastography in Glioma: Exploring Tumor Stiffness and Adhesion

Not Applicable

Recruiting

• Conditions: Glioma
• Interventions: Diagnostic Test: Magnetic Resonance Elastography; Procedure: Assessment and Recording

• Registration Number: NCT05990244
• Lead Sponsor: Shengjing Hospital

Brief Summary

this study will investigate the relationship between tumor stiffness and adhesion in gliomas using MRE. By utilizing preoperative MRE and Intraoperative neuronavigation, followed by comprehensive molecular pathology analysis, we aim to explore the correlation of tumor stiffness and adhesion with molecular and genetic characteristics of gliomas. Additionally, the predictive value of MRE in terms of pathological staging and prognosis will be determined. This research may pave the way for improved clinical decision-making, personalized treatment approaches, and more accurate clinical trials for glioma patients.

Detailed Description

Magnetic Resonance Elastography (MRE) is an advanced imaging technique that measures the mechanical properties of tissues, providing valuable information about tissue stiffness, elasticity, and adhesion. In the case of gliomas, a type of brain tumor arising from glial cells, MRE has shown promising potential in the diagnosis, classification, and prediction of pathological and molecular features.

This clinical trial aims to investigate the relationship between tumor stiffness, adhesion, glioma grading, and genetic alterations by combining magnetic resonance elastography (MRE) imaging findings with molecular pathological analysis. Moreover, the study aims to predict patient survival based on the physical properties of the tumor.

Preoperatively, we will use MRE to enhance the accuracy of navigation and determine tumor stiffness and adhesion properties. Intraoperatively, under the guidance of neuronavigation, tissue samples will be obtained, and the operating surgeon will assess the tumor's stiffness, elasticity, and degree of adhesion.

Postoperatively, all tissue specimens will undergo molecular pathological analysis. The integration of MRE findings with molecular pathology data will enable precise classification and subtyping of gliomas.

Furthermore, all patients will receive systematic treatment after surgery, and long-term follow-ups will be conducted. This comprehensive approach combining MRE, molecular pathology analysis, and clinical follow-up aims to investigate the predictive value of MRE in terms of molecular pathological features and prognosis in gliomas.

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2023-08-06
• Study First Submitted QC: 2023-08-06
• Study First Posted: 2023-08-14
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2026-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All patients undergoing glioma resection surgery are eligible for inclusion in the study cohort.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (MRE, tumor grade, tumor stiffness and adhesion)	Magnetic Resonance Elastography	Patients undergo a preoperative routine MRI scan and MRE the day before their scheduled surgery to assess tumor stiffness and adhesion. Additionally, molecular pathological analysis will be performed to identify genetic alterations in gliomas. During surgery, the tumor stiffness and adhesion will be 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 before the surgery. This information is typically obtained through intraoperative assessment and observation.
Diagnostic (MRE, tumor grade, tumor stiffness and adhesion)	Assessment and Recording	Patients undergo a preoperative routine MRI scan and MRE the day before their scheduled surgery to assess tumor stiffness and adhesion. Additionally, molecular pathological analysis will be performed to identify genetic alterations in gliomas. During surgery, the tumor stiffness and adhesion will be 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 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.
Radiological assessment of tumor stiffness	Baseline to 6 weeks	Tumor stiffness, measured in kilopascals (kPa), will be compared with its normal-appearing contralateral white matter using MRE by creating a lesion region of interest (ROI). Images were acquired on a 3T MR imaging unit with a vibration frequency of 60 Hz. The performance of the use of tumor stiffness to predict tumor grade was evaluated with the Wilcoxon rank sum, 1-way ANOVA, and Tukey-Kramer tests.
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