Magnetic Resonance Elastography in Glioma: Exploring Tumor Stiffness and Adhesion

NCT05990244 | Recruiting DMC

• 1 other identifier: ShengjingH_glioma2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

this study will investigate the relationship between tumor stiffness and adhesion in gliomas using MRE. By utilizing preoperative MRE and Intraoperative neuronavigation, followed by comprehensive molecular pathology analysis, we aim to explore the correlation of tumor stiffness and adhesion with molecular and genetic characteristics of gliomas. Additionally, the predictive value of MRE in terms of pathological staging and prognosis will be determined. This research may pave the way for improved clinical decision-making, personalized treatment approaches, and more accurate clinical trials for glioma patients.

Conditions

Glioma

Keywords

Magnetic Resonance Elastography; Brain tumor; Glioblastoma; MR elastography; Tumor molecular pathology

Outcome Measures

Primary Outcomes (3)

• Surgical assessment of tumor stiffness

  The surgeon will score the tumor stiffness in seven aspects, ranging from 1 to 5 points: Tumor size; Shape of tumor; Tumor texture; Stiffness of the tumor's capsule; Stiffness of the tumor's central region; Primary methods of tumor removal; Features of tumor's capsule.

  Baseline to 6 weeks

• Surgical assessment of tumor adhesion

  The surgeon will score the tumor's adhesion based on seven aspects, ranging from 1 to 4 points: Stripping instruments; Frequency of use of sharp instruments; Adhesion range; Degree of tumor resection; Cranial nerve anatomy preservation; Brain tissue anatomy preservation; Neurological function (compared with preoperative).

  Baseline to 6 weeks

• Radiological assessment of tumor stiffness

  Tumor stiffness, measured in kilopascals (kPa), will be compared with its normal-appearing contralateral white matter using MRE by creating a lesion region of interest (ROI). Images were acquired on a 3T MR imaging unit with a vibration frequency of 60 Hz. The performance of the use of tumor stiffness to predict tumor grade was evaluated with the Wilcoxon rank sum, 1-way ANOVA, and Tukey-Kramer tests.

  MRE performed within one week before surgery

Study Arms (1)

Diagnostic (MRE, tumor grade, tumor stiffness and adhesion)

EXPERIMENTAL

Patients undergo a preoperative routine MRI scan and MRE the day before their scheduled surgery to assess tumor stiffness and adhesion. Additionally, molecular pathological analysis will be performed to identify genetic alterations in gliomas. During surgery, the tumor stiffness and adhesion will be assessed and recorded by the surgeon according to established evaluation criteria. It is important to note that the surgeon does not have prior knowledge of the tumor's specific stiffness before the surgery. This information is typically obtained through intraoperative assessment and observation.

Diagnostic Test: Magnetic Resonance Elastography; Procedure: Assessment and Recording

Interventions

Magnetic Resonance Elastography DIAGNOSTIC_TEST

Undergo MRE and routine MRI

Also known as: MRE

Diagnostic (MRE, tumor grade, tumor stiffness and adhesion)

Assessment and Recording PROCEDURE

Undergo recording of tumor stiffness during surgery and molecular pathological classification through genetic analysis

Diagnostic (MRE, tumor grade, tumor stiffness and adhesion)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age older than 18 years
• Karnofsky performance status higher than 60
• with written informed consent
• MRE performed within one week before surgery
• tumor diameter \> 2 cm

You may not qualify if:

• previous treatment for glioma
• inability to complete MRE due to intolerance (e.g., vibration-related discomfort or claustrophobia)
• completed MRE with suboptimal wave image quality (e.g., motion artifacts or inad-equate wave amplitude)
• failure to proceed with surgery after MRE
• missing IDH results

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110000, China

RECRUITING

Related Publications (5)

• Murphy MC, Huston J 3rd, Glaser KJ, Manduca A, Meyer FB, Lanzino G, Morris JM, Felmlee JP, Ehman RL. Preoperative assessment of meningioma stiffness using magnetic resonance elastography. J Neurosurg. 2013 Mar;118(3):643-8. doi: 10.3171/2012.9.JNS12519. Epub 2012 Oct 19.

  PMID: 23082888 BACKGROUND

• 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.

  PMID: 26197204 BACKGROUND

• Yin 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.

  PMID: 33852045 BACKGROUND

• Yin 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.

  PMID: 28194925 BACKGROUND

• Pepin KM, McGee KP, Arani A, Lake DS, Glaser KJ, Manduca A, Parney IF, Ehman RL, Huston J 3rd. MR Elastography Analysis of Glioma Stiffness and IDH1-Mutation Status. AJNR Am J Neuroradiol. 2018 Jan;39(1):31-36. doi: 10.3174/ajnr.A5415. Epub 2017 Oct 26.

  PMID: 29074637 BACKGROUND

MeSH Terms

Conditions

Glioma; Brain Neoplasms; Glioblastoma

Interventions

Elasticity Imaging Techniques; Restraint, Physical

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Astrocytoma

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Yu Shi, MD

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

• Anhua Wu, MD

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

• Wen Cheng, MD

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

• Xiufang A( Ren, MD

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Shi, MD

CONTACT

+86 189 4025 9980; 18940259980@163.com

Yu Zeng, PhD

CONTACT

+86 133 0721 0101; yzengdsg@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of department of radology

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: August 14, 2023
• Study Start: January 1, 2017
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)