Clinical trial NCT06955208: 3D MRE-Based Evaluation of Meningioma Mechanical Properties and Histological Features
Official title: Evaluation of Meningioma Mechanical Properties and Histological Features Using Three-Dimensional Magnetic Resonance Elastography
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Meningioma
Keywords: Magnetic resonance elastography
Meningioma
Stiffness
Adhesion
Neurosurgery
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Agreement Between MRE Stiffness and Intraoperative Tumor Consistency
timeFrame: Intraoperative (Day of Surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang,
country: China
facility: Shengjing Hospital
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Yu Shi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shengjing Hospital
name: Anhua Wu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shengjing Hospital
name: Wen Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.