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Enrolling by invitationNCT07844460Updated Sep 28, 2026

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

An observational study in Vestibular Schwannoma, sponsored by Shengjing Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Shengjing Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Vestibular Schwannoma

Keywords

  • Stiffness
  • Adhesion
  • Neurosurgery
  • Vestibular schwannoma
  • Magnetic resonance elastography
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study will enroll adult patients with unilateral sporadic vestibular schwannoma who are scheduled to undergo microsurgical resection at Shengjing hospital.

Inclusion criteria

  • All patients undergoing vestibular schwannoma resection surgery are eligible for inclusion in the study cohort.

Exclusion criteria

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

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.

    Time frame: Intraoperative (Day of Surgery)

06

Study locations

1 site
  • Shengjing hospital
    Shenyang, Liaoning 110000, China
07

References and documents

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 41376349 ↗
  • Duhon 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 38914647 ↗
  • Yin 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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07844460
Lead sponsor
Shengjing Hospital
Responsible party
Wen Cheng (Professor, Shengjing Hospital) — Principal investigator
First posted
Sep 28, 2026
Start date
Sep 25, 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Mar 2027 (estimated)
Last update
Sep 28, 2026

Study contacts

Anhua Wu, MD
principal investigator · Shengjing Hospital
wen Cheng, MD
principal investigator · Shengjing Hospital
Yu Shi, MD
principal investigator · Shengjing Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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