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Recruiting NCT06955208

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

No phase Interventional Meningioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnetic Resonance Elastography, Intraoperative Assessment and Recording.
Who it may be relevant to
Registry conditions: Meningioma. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Agreement Between MRE Stiffness and Intraoperative Tumor Consistency [Time frame: Intraoperative (Day of Surgery)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Shengjing Hospital — Shenyang

Publications

  • 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. PMID 26197204
  • 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. PMID 33852045
  • 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. PMID 28194925

Identifiers

NCT: NCT06955208 · 2022_meningioma

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗