NCT07844460

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
5mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Sep 2026Mar 2027

First Submitted

Initial submission to the registry

September 21, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

September 25, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

September 21, 2026

Last Update Submit

September 21, 2026

Conditions

Keywords

StiffnessAdhesionNeurosurgeryVestibular schwannomaMagnetic resonance elastography

Outcome Measures

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.

    Intraoperative (Day of Surgery)

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengjing hospital

Shenyang, Liaoning, 110000, China

Location

Related Publications (3)

  • 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.

    PMID: 41376349BACKGROUND
  • 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.

    PMID: 38914647BACKGROUND
  • 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.

MeSH Terms

Conditions

Neuroma, AcousticTissue Adhesions

Condition Hierarchy (Ancestors)

NeurilemmomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueCranial Nerve NeoplasmsNervous System NeoplasmsNeoplasms by SitePeripheral Nervous System NeoplasmsVestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsCranial Nerve DiseasesNervous System DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anhua Wu, MD

    Shengjing Hospital

    PRINCIPAL INVESTIGATOR
  • wen Cheng, MD

    Shengjing Hospital

    PRINCIPAL INVESTIGATOR
  • Yu Shi, MD

    Shengjing Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 21, 2026

First Posted

September 28, 2026

Study Start

September 25, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

September 28, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations