Vestibular SchwannomaNCT07844460
3D MRE-Based Evaluation of Vestibular Schwannoma Mechanical Properties and Histological Features
An observational study of Vestibular Schwannoma, 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 vestibular schwannoma undergoing surgical resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vestibular Schwannoma
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2025to Mar 2027
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll adult patients with unilateral sporadic vestibular schwannoma who are scheduled to undergo microsurgical resection at Shengjing hospital.
Who may be able to join
- -All patients undergoing vestibular schwannoma 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
wen cheng, MD, 18940250139, cmu071207@163.com
About this study
Official title: Evaluation of Vestibular Schwannoma 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 vestibular schwannoma 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 risk stratification and prediction of tumor behavior, and to evaluate the relationship between MRE characterization of tumor mechanical features and patients' clinical prognosis.
Read the detailed description
Vestibular schwannomas are the most common tumors in the cerebellopontine angle and are generally amenable to microsurgical resection. However, the intraoperative biomechanical characteristics of these tumors, particularly their stiffness and adhesion to adjacent neurovascular structures, vary considerably among patients and have a direct impact on surgical difficulty, extent of resection, postoperative complications, and functional outcomes. Current preoperative imaging modalities provide limited information regarding these biomechanical properties, making it difficult to accurately predict surgical complexity and facilitate individualized surgical planning and preoperative patient counseling.
This prospective clinical study aims to evaluate the feasibility and clinical value of three-dimensional magnetic resonance elastography (3D MRE) for the preoperative assessment of vestibular schwannomas. Specifically, quantitative MRE-derived biomechanical parameters, including tumor stiffness and adhesion-related characteristics based on shear modulus maps, will be compared with intraoperative surgeon-assessed tumor stiffness, adhesion, vascularity, surgical difficulty, and postoperative histopathological findings. In addition, postoperative facial nerve function will be longitudinally evaluated to investigate the association between preoperative MRE findings and functional prognosis.
Approximately 30 patients with radiologically confirmed vestibular schwannomas who are scheduled to undergo elective microsurgical resection will be prospectively enrolled. All participants will receive routine preoperative MRI together with an additional 3D MRE examination. During surgery, standardized assessments of tumor stiffness, adhesion to surrounding structures, vascularity, and resection difficulty will be recorded by the operating neurosurgeons. Postoperative clinical follow-up will include facial nerve function assessment and collection of other relevant clinical outcome measures.
Statistical analyses will be performed to evaluate the correlations between MRE-derived biomechanical parameters and intraoperative findings, histopathological features, and postoperative outcomes, as well as to assess the diagnostic performance and prognostic value of 3D MRE.
Findings of this study are expected to establish 3D MRE as a noninvasive imaging biomarker for the preoperative characterization of vestibular schwannomas, thereby improving surgical planning, enhancing patient counseling, reducing perioperative complications, and ultimately optimizing clinical decision-making.
- Conditions
- Vestibular Schwannoma
- Keywords
- Stiffness, Adhesion, Neurosurgery, Vestibular schwannoma, Magnetic resonance elastography
- Medical subject headings
- Neuroma, Acoustic, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MRE diagnostic test group | Participants in this group will undergo preoperative three-dimensional magnetic resonance elastography (3D MRE) . MRE will be used to quantify tumor stiffness and generate a three-dimensional adhesion map. The facial nerve function after surgery will be followed up 3 - 6 months after the operation. |
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 posted28 Sep 2026
- Study start25 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 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 Vestibular SchwannomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen Cheng, Shengjing Hospital
- Investigators
- Anhua Wu, MD, Principal investigator, Shengjing Hospitalwen Cheng, MD, Principal investigator, Shengjing HospitalYu Shi, MD, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844460
- Sponsor's protocol ID
- 2026_Vestibular Schwannoma
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng W, Bai S, Zeng Y, Zheng K, Hong Y, Han S, Zhang T, Guo M, Liu T, Wu J, Manduca A, Huston Iii J, Sheng Y, Wu Q, Jiao N, Yin Z, Shi Y, Wu A. Magnetic resonance elastography characterization of meningioma mechanical properties for improved neurosurgical planning and resection a prospective cohort study. Int J Surg. 2025 Dec 11. doi: 10.1097/JS9.0000000000004199. Online ahead of print.
PubMed 41376349Duhon BH, Thompson K, Fisher M, Kaul VF, Nguyen HT, Harris MS, Varadarajan V, Adunka OF, Prevedello DM, Kolipaka A, Ren Y. Tumor biomechanical stiffness by magnetic resonance elastography predicts surgical outcomes and identifies biomarkers in vestibular schwannoma and meningioma. Sci Rep. 2024 Jun 24;14(1):14561. doi: 10.1038/s41598-024-64597-1.
PubMed 38914647Yin Z, Glaser KJ, Manduca A, Van Gompel JJ, Link MJ, Hughes JD, Romano A, Ehman RL, Huston J 3rd. Slip Interface Imaging Predicts Tumor-Brain Adhesion in Vestibular Schwannomas. Radiology. 2015 Nov;277(2):507-17. doi: 10.1148/radiol.2015151075. Epub 2015 Aug 6.
PubMed 26247776
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vestibular Schwannoma Mechanical Properties and Histological Features Using Three-Dimensional Magnetic Resonance Elastography
- ClinicalTrials.gov ID
- NCT07844460
- Acronym / sponsor ID
- 2026_Vestibular Schwannoma
- Conditions
- Vestibular Schwannoma
- Keywords
- Stiffness, Adhesion, Neurosurgery, Vestibular schwannoma, Magnetic resonance elastography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Sep 2026 (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 vestibular schwannoma 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 risk stratification and prediction of tumor behavior, and to evaluate the relationship between MRE characterization of tumor mechanical features and patients' clinical prognosis.
Detailed description
Vestibular schwannomas are the most common tumors in the cerebellopontine angle and are generally amenable to microsurgical resection. However, the intraoperative biomechanical characteristics of these tumors, particularly their stiffness and adhesion to adjacent neurovascular structures, vary considerably among patients and have a direct impact on surgical difficulty, extent of resection, postoperative complications, and functional outcomes. Current preoperative imaging modalities provide limited information regarding these biomechanical properties, making it difficult to accurately predict surgical complexity and facilitate individualized surgical planning and preoperative patient counseling.
This prospective clinical study aims to evaluate the feasibility and clinical value of three-dimensional magnetic resonance elastography (3D MRE) for the preoperative assessment of vestibular schwannomas. Specifically, quantitative MRE-derived biomechanical parameters, including tumor stiffness and adhesion-related characteristics based on shear modulus maps, will be compared with intraoperative surgeon-assessed tumor stiffness, adhesion, vascularity, surgical difficulty, and postoperative histopathological findings. In addition, postoperative facial nerve function will be longitudinally evaluated to investigate the association between preoperative MRE findings and functional prognosis.
Approximately 30 patients with radiologically confirmed vestibular schwannomas who are scheduled to undergo elective microsurgical resection will be prospectively enrolled. All participants will receive routine preoperative MRI together with an additional 3D MRE examination. During surgery, standardized assessments of tumor stiffness, adhesion to surrounding structures, vascularity, and resection difficulty will be recorded by the operating neurosurgeons. Postoperative clinical follow-up will include facial nerve function assessment and collection of other relevant clinical outcome measures.
Statistical analyses will be performed to evaluate the correlations between MRE-derived biomechanical parameters and intraoperative findings, histopathological features, and postoperative outcomes, as well as to assess the diagnostic performance and prognostic value of 3D MRE.
Findings of this study are expected to establish 3D MRE as a noninvasive imaging biomarker for the preoperative characterization of vestibular schwannomas, thereby improving surgical planning, enhancing patient counseling, reducing perioperative complications, and ultimately optimizing clinical decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRE diagnostic test group | – | –Participants in this group will undergo preoperative three-dimensional magnetic resonance elastography (3D MRE) . MRE will be used to quantify tumor stiffness and generate a three-dimensional adhesion map. The facial nerve function after surgery will be followed up 3 - 6 months after the operation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll adult patients with unilateral sporadic vestibular schwannoma who are scheduled to undergo microsurgical resection at Shengjing hospital.
Key inclusion criteria (1 listed)
- -All patients undergoing vestibular schwannoma 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.
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 16 Oct 2026.
- Background: PubMed 41376349Cheng W, Bai S, Zeng Y, Zheng K, Hong Y, Han S, Zhang T, Guo M, Liu T, Wu J, Manduca A, Huston Iii J, Sheng Y, Wu Q, Jiao N, Yin Z, Shi Y, Wu A. Magnetic resonance elastography characterization of meningioma mechanical properties for improved neurosurgical planning and resection a prospective cohort study. Int J Surg. 2025 Dec 11. doi: 10.1097/JS9.0000000000004199. Online ahead of print.
- Background: PubMed 38914647Duhon BH, Thompson K, Fisher M, Kaul VF, Nguyen HT, Harris MS, Varadarajan V, Adunka OF, Prevedello DM, Kolipaka A, Ren Y. Tumor biomechanical stiffness by magnetic resonance elastography predicts surgical outcomes and identifies biomarkers in vestibular schwannoma and meningioma. Sci Rep. 2024 Jun 24;14(1):14561. doi: 10.1038/s41598-024-64597-1.
- Results publication: PubMed 26247776Yin Z, Glaser KJ, Manduca A, Van Gompel JJ, Link MJ, Hughes JD, Romano A, Ehman RL, Huston J 3rd. Slip Interface Imaging Predicts Tumor-Brain Adhesion in Vestibular Schwannomas. Radiology. 2015 Nov;277(2):507-17. doi: 10.1148/radiol.2015151075. Epub 2015 Aug 6.
- 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.
Anhua Wu, MD principal investigator
Shengjing Hospital
wen Cheng, MD principal investigator
Shengjing Hospital
Yu Shi, 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?
An observational study of Vestibular Schwannoma, 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 16 Oct 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 wen Cheng, MD (18940250139, cmu071207@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 NCT07844460, 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 16 Oct 2026.