NCT06955208

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Oct 2022Oct 2027

Study Start

First participant enrolled

October 19, 2022

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 2, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2027

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

April 24, 2025

Last Update Submit

February 10, 2026

Conditions

Keywords

Magnetic resonance elastographyMeningiomaStiffnessAdhesionNeurosurgery

Outcome Measures

Primary Outcomes (1)

  • Agreement Between MRE Stiffness and Intraoperative Tumor Consistency

    The primary outcome is the correlation between preoperative 3D MRE-derived shear stiffness values and intraoperative tumor consistency as assessed by the neurosurgeon using a standardized ordinal scale (1-5). Agreement will be evaluated using Spearman correlation and Bland-Altman analysis.

    Intraoperative (Day of Surgery)

Study Arms (1)

MRE-Guided Surgery Group

EXPERIMENTAL

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.

Diagnostic Test: Magnetic Resonance ElastographyProcedure: Intraoperative Assessment and Recording

Interventions

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.

Also known as: MRE
MRE-Guided Surgery Group

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.

MRE-Guided Surgery Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110000, China

RECRUITING

Related Publications (3)

  • 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: 26197204BACKGROUND
  • 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: 33852045BACKGROUND
  • 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: 28194925BACKGROUND

MeSH Terms

Conditions

MeningiomaTissue Adhesions

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Neoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueMeningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNervous System DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Yu Shi, MD

    Shengjing Hospital

    PRINCIPAL INVESTIGATOR
  • Anhua Wu, MD

    Shengjing Hospital

    PRINCIPAL INVESTIGATOR
  • Wen Cheng, MD

    Shengjing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 2, 2025

Study Start

October 19, 2022

Primary Completion (Estimated)

October 9, 2026

Study Completion (Estimated)

October 9, 2027

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations