MeningiomaNCT06955208
3D MRE-Based Evaluation of Meningioma Mechanical Properties and Histological Features
A study testing Magnetic Resonance Elastography and Intraoperative Assessment and Recording in people with Meningioma, run by Shengjing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningioma
- What is being tested?
- Magnetic Resonance Elastography and Intraoperative Assessment and Recording
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2022to 9 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients undergoing meningeoma resection surgery are eligible for inclusion in the study cohort.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shengjing Hospital
Shenyang, Liaoning, 110000
Yu Shi, MD, +86 189 4025 9980, 18940259980@163.com
Anhua Wu, MD, +86 189 0092 5766, cmu071207@163.com
About this study
Official title: Evaluation of Meningioma Mechanical Properties and Histological Features Using Three-Dimensional Magnetic Resonance Elastography
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.
Read the 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
- Meningioma
- Being tested
- Magnetic Resonance Elastography, Intraoperative Assessment and Recording
- Keywords
- Magnetic resonance elastography, Meningioma, Stiffness, Adhesion, Neurosurgery
- Medical subject headings
- Meningioma, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ElastographyDiagnostic test
Also called MRE
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.
Intraoperative Assessment and RecordingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Magnetic Resonance Elastography; Procedure: Intraoperative Assessment and Recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative (Day of Surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start19 Oct 2022
- Primary completion9 Oct 2026 (estimated)
- Study completion9 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Shi, Shengjing Hospital
- Investigators
- Yu Shi, MD, Principal investigator, Shengjing HospitalAnhua Wu, MD, Principal investigator, Shengjing HospitalWen Cheng, MD, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955208
- Sponsor's protocol ID
- 2022_meningioma
- Status last verified
- Feb 2026
- First submitted
- 24 Apr 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26197204Yin 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.
PubMed 33852045Yin 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.
PubMed 28194925
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Meningioma Mechanical Properties and Histological Features Using Three-Dimensional Magnetic Resonance Elastography
- ClinicalTrials.gov ID
- NCT06955208
- Acronym / sponsor ID
- 2022_meningioma
- Conditions
- Meningioma
- Keywords
- Magnetic resonance elastography, Meningioma, Stiffness, Adhesion, Neurosurgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 9 Oct 2026 (estimated)
- Study completion
- 9 Oct 2027 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRE-Guided Surgery Group | Experimental | Diagnostic Test: Magnetic Resonance Elastography, Procedure: Intraoperative Assessment and RecordingParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing meningeoma resection surgery are eligible for inclusion in the study cohort.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ElastographyAlso: MREParticipants 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. | Diagnostic test | MRE-Guided Surgery Group |
| Intraoperative Assessment and RecordingDuring 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. | Procedure or surgery | MRE-Guided Surgery Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background: PubMed 26197204Hughes 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.
- Background: PubMed 33852045Yin 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.
- Background: PubMed 28194925Yin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yu Shi, MD principal investigator
Shengjing Hospital
Anhua Wu, MD principal investigator
Shengjing Hospital
Wen Cheng, MD principal investigator
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Elastography and Intraoperative Assessment and Recording in people with Meningioma, run by Shengjing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Shi, MD (+86 189 4025 9980, 18940259980@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between MRE Stiffness and Intraoperative Tumor Consistency (time frame: Intraoperative (Day of Surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06955208, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.