Trials / Recruiting
RecruitingNCT06955208
3D MRE-Based Evaluation of Meningioma Mechanical Properties and Histological Features
Evaluation of Meningioma Mechanical Properties and Histological Features Using Three-Dimensional Magnetic Resonance Elastography
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Shengjing Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | 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. |
| PROCEDURE | 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. |
Timeline
- Start date
- 2022-10-19
- Primary completion
- 2026-10-09
- Completion
- 2027-10-09
- First posted
- 2025-05-02
- Last updated
- 2026-02-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06955208. Inclusion in this directory is not an endorsement.