3D MRE-Based Evaluation of Meningioma Mechanical Properties and Histological Features

NCT ID: NCT06955208

Last Updated: 2026-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-19
• Study Completion Date: 2027-10-09

Brief Summary

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.

Detailed Description

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.

Conditions

Meningioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MRE-Guided Surgery Group

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.

Group Type: EXPERIMENTAL

Magnetic Resonance Elastography

Intervention Type: DIAGNOSTIC_TEST

Participants will undergo preoperative 3D MRE to quantify tumor stiffness and generate adhesion maps. MRE is performed as an adjunct to standard brain MRI, using 60 Hz vibration frequency and specialized elastogram processing software. The resulting stiffness and adhesion data are made available to the neurosurgical team for surgical planning.

Intraoperative Assessment and Recording

Intervention Type: PROCEDURE

During surgical resection, the neurosurgical team will systematically assess and record tumor stiffness, adhesion to surrounding structures, vascularity, resection time, and technical difficulty using a standardized intraoperative scale. These intraoperative findings will be compared to preoperative MRE parameters to evaluate the diagnostic and predictive value of MRE.

Interventions

Magnetic Resonance Elastography

Participants will undergo preoperative 3D MRE to quantify tumor stiffness and generate adhesion maps. MRE is performed as an adjunct to standard brain MRI, using 60 Hz vibration frequency and specialized elastogram processing software. The resulting stiffness and adhesion data are made available to the neurosurgical team for surgical planning.

Intervention Type: DIAGNOSTIC_TEST

Intraoperative Assessment and Recording

During surgical resection, the neurosurgical team will systematically assess and record tumor stiffness, adhesion to surrounding structures, vascularity, resection time, and technical difficulty using a standardized intraoperative scale. These intraoperative findings will be compared to preoperative MRE parameters to evaluate the diagnostic and predictive value of MRE.

Intervention Type: PROCEDURE

Other Intervention Names

MRE

Eligibility Criteria

Inclusion Criteria

• All patients undergoing meningeoma 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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shengjing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yu Shi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yu Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Anhua Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Wen Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Locations

Shengjing Hospital

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yu Shi, MD

Role: CONTACT

18940259980@163.com

+86 189 4025 9980

Wen Cheng, MD

Role: CONTACT

cmu071207@163.com

15040235535

Facility Contacts

Yu Shi, MD

Role: primary

18940259980@163.com

+86 189 4025 9980

Anhua Wu, MD

Role: backup

cmu071207@163.com

+86 189 0092 5766

References

Hughes JD, Fattahi N, Van Gompel J, Arani A, Meyer F, Lanzino G, Link MJ, Ehman R, Huston J. Higher-Resolution Magnetic Resonance Elastography in Meningiomas to Determine Intratumoral Consistency. Neurosurgery. 2015 Oct;77(4):653-8; discussion 658-9. doi: 10.1227/NEU.0000000000000892.

Reference Type: BACKGROUND

PMID: 26197204 (View on PubMed)

Yin Z, Lu X, Cohen Cohen S, Sui Y, Manduca A, Van Gompel JJ, Ehman RL, Huston J 3rd. A new method for quantification and 3D visualization of brain tumor adhesion using slip interface imaging in patients with meningiomas. Eur Radiol. 2021 Aug;31(8):5554-5564. doi: 10.1007/s00330-021-07918-6. Epub 2021 Apr 14.

Reference Type: BACKGROUND

PMID: 33852045 (View on PubMed)

Yin Z, Hughes JD, Trzasko JD, Glaser KJ, Manduca A, Van Gompel J, Link MJ, Romano A, Ehman RL, Huston J 3rd. Slip interface imaging based on MR-elastography preoperatively predicts meningioma-brain adhesion. J Magn Reson Imaging. 2017 Oct;46(4):1007-1016. doi: 10.1002/jmri.25623. Epub 2017 Feb 14.

Reference Type: BACKGROUND

PMID: 28194925 (View on PubMed)

Other Identifiers

2022_meningioma

Identifier Type: -

Identifier Source: org_study_id