Magnetic Resonance Elastography in Glioma: Exploring Tumor Stiffness and Adhesion

Glioma Clinical Trial

Official title:

Comprehensive Assessment of Tumor Stiffness and Adhesion in Glioma Using Magnetic Resonance Elastography: A Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05990244
• Other study ID #: ShengjingH_glioma2023
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: August 2023
• Source: Shengjing Hospital
• Contact: Yu Shi, MD
• Phone: +86 189 4025 9980
• Email: 18940259980[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Magnetic Resonance Elastography (MRE) is an advanced imaging technique that measures the mechanical properties of tissues, providing valuable information about tissue stiffness, elasticity, and adhesion. In the case of gliomas, a type of brain tumor arising from glial cells, MRE has shown promising potential in the diagnosis, classification, and prediction of pathological and molecular features.

This clinical trial aims to investigate the relationship between tumor stiffness, adhesion, glioma grading, and genetic alterations by combining magnetic resonance elastography (MRE) imaging findings with molecular pathological analysis. Moreover, the study aims to predict patient survival based on the physical properties of the tumor.

Preoperatively, we will use MRE to enhance the accuracy of navigation and determine tumor stiffness and adhesion properties. Intraoperatively, under the guidance of neuronavigation, tissue samples will be obtained, and the operating surgeon will assess the tumor's stiffness, elasticity, and degree of adhesion.

Postoperatively, all tissue specimens will undergo molecular pathological analysis. The integration of MRE findings with molecular pathology data will enable precise classification and subtyping of gliomas.

Furthermore, all patients will receive systematic treatment after surgery, and long-term follow-ups will be conducted. This comprehensive approach combining MRE, molecular pathology analysis, and clinical follow-up aims to investigate the predictive value of MRE in terms of molecular pathological features and prognosis in gliomas.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with metallic implants or foreign bodies in their bodies (pacemakers, artificial metallic heart valves, metal joints, metal implants, and those who cannot 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

Related Conditions & MeSH terms

• Glioma

Intervention

Diagnostic Test:
• Magnetic Resonance Elastography
Undergo MRE and routine MRI

Procedure:
• Assessment and Recording
Undergo recording of tumor stiffness during surgery and molecular pathological classification through genetic analysis

Locations

Country	Name	City	State
China	Shengjing Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: J Magn Reson Imaging. 2017 Dec;46(6):1851. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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.	Baseline to 6 weeks