- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06955208
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yu Shi, MD
- Phone Number: +86 189 4025 9980
- Email: 18940259980@163.com
Study Contact Backup
- Name: Wen Cheng, MD
- Phone Number: 15040235535
- Email: cmu071207@163.com
Study Locations
-
-
Liaoning
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Shenyang, Liaoning, China, 110000
- Recruiting
- Shengjing Hospital
-
Contact:
- Yu Shi, MD
- Phone Number: +86 189 4025 9980
- Email: 18940259980@163.com
-
Principal Investigator:
- Wen Cheng
-
Contact:
- Anhua Wu, MD
- Phone Number: +86 189 0092 5766
- Email: cmu071207@163.com
-
Principal Investigator:
- Yu Shi
-
Principal Investigator:
- Anhua Wu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
Other Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Agreement Between MRE Stiffness and Intraoperative Tumor Consistency
Time Frame: Intraoperative (Day of Surgery)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yu Shi, MD, Shengjing Hospital
- Principal Investigator: Anhua Wu, MD, Shengjing Hospital
- Principal Investigator: Wen Cheng, MD, Shengjing Hospital
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Neoplasms, Nerve Tissue
- Nervous System Neoplasms
- Neoplasms, Vascular Tissue
- Meningeal Neoplasms
- Central Nervous System Neoplasms
- Cicatrix
- Fibrosis
- Pathological Conditions, Signs and Symptoms
- Meningioma
- Tissue Adhesions
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Imaging
- Ultrasonography
- Elasticity Imaging Techniques
Other Study ID Numbers
- 2022_meningioma
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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