An observational study in Vestibular Schwannoma, sponsored by Shengjing Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Shengjing Hospital · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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.
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.
100 studies on the registry are indexed under Neuroma, Acoustic; 28 are open to participants now.
This study's planned enrollment of 30 is below the median of 61 across 26 observational studies indexed under Neuroma, Acoustic.
Browse Neuroma, Acoustic studies →Shengjing Hospital is the lead sponsor of 127 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 14, 2026. See what changed
This study will enroll adult patients with unilateral sporadic vestibular schwannoma who are scheduled to undergo microsurgical resection at Shengjing hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
-All patients undergoing vestibular schwannoma resection surgery are eligible for inclusion in the study cohort.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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)
Plan to share: No
Started Sep 2025 (actual). Primary completion is estimated for Dec 2026, 15 months after the start.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Sep 2025, on Oct 16, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.