GliomaNCT05990244
Magnetic Resonance Elastography in Glioma: Exploring Tumor Stiffness and Adhesion
A study testing Magnetic Resonance Elastography and Assessment and Recording in people with Glioma, run by Shengjing Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glioma
- What is being tested?
- Magnetic Resonance Elastography and Assessment and Recording
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shengjing Hospital
Shenyang, Liaoning, 110000
Yu Shi, MD, +8618940259980, 18940259980@163.com
Anhua Wu, MD, +8618900925766, wuanhua@yahoo.com
About this study
Official title: Comprehensive Assessment of Tumor Stiffness and Adhesion in Glioma Using Magnetic Resonance Elastography: A Prospective Study
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.
Read the detailed 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.
- Conditions
- Glioma
- Being tested
- Magnetic Resonance Elastography, Assessment and Recording
- Keywords
- Magnetic Resonance Elastography, Brain tumor, Glioblastoma, MR elastography, Tumor molecular pathology
- Medical subject headings
- Glioma, Brain Neoplasms, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ElastographyDiagnostic test
Also called MRE
Undergo MRE and routine MRI
Assessment and RecordingProcedure or surgery
Undergo recording of tumor stiffness during surgery and molecular pathological classification through genetic analysis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Magnetic Resonance Elastography; Procedure: Assessment and Recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: MRE performed within one week before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jan 2017
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Shi, Shengjing Hospital
- Investigators
- Yu Shi, MD, Principal investigator, Shengjing HospitalAnhua Wu, MD, Principal investigator, Shengjing HospitalWen Cheng, MD, Principal investigator, Shengjing HospitalXiufang A( Ren, MD, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990244
- Sponsor's protocol ID
- ShengjingH_glioma2023
- Status last verified
- Nov 2025
- First submitted
- 6 Aug 2023
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23082888Hughes 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.
PubMed 26197204Yin 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.
PubMed 33852045Yin 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.
PubMed 28194925Pepin 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.
PubMed 29074637
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Assessment of Tumor Stiffness and Adhesion in Glioma Using Magnetic Resonance Elastography: A Prospective Study
- ClinicalTrials.gov ID
- NCT05990244
- Acronym / sponsor ID
- ShengjingH_glioma2023
- Conditions
- Glioma
- Keywords
- Magnetic Resonance Elastography, Brain tumor, Glioblastoma, MR elastography, Tumor molecular pathology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (MRE, tumor grade, tumor stiffness and adhesion) | Experimental | Diagnostic Test: Magnetic Resonance Elastography, Procedure: Assessment and RecordingPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ElastographyAlso: MREUndergo MRE and routine MRI | Diagnostic test | Diagnostic (MRE, tumor grade, tumor stiffness and adhesion) |
| Assessment and RecordingUndergo recording of tumor stiffness during surgery and molecular pathological classification through genetic analysis | Procedure or surgery | Diagnostic (MRE, tumor grade, tumor stiffness and adhesion) |
Primary outcome
Surgical assessment of tumor stiffness
Time frame: Baseline to 6 weeks
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.
Surgical assessment of tumor adhesion
Time frame: Baseline to 6 weeks
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).
Radiological assessment of tumor stiffness
Time frame: MRE performed within one week before surgery
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Background: PubMed 23082888Murphy 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.
- Background: PubMed 26197204Hughes 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.
- Background: PubMed 33852045Yin 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.
- Background: PubMed 28194925Yin 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.
- Background: PubMed 29074637Pepin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yu Shi, MD principal investigator
Shengjing Hospital
Anhua Wu, MD principal investigator
Shengjing Hospital
Wen Cheng, MD principal investigator
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Elastography and Assessment and Recording in people with Glioma, run by Shengjing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Shi, MD (+86 189 4025 9980, 18940259980@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical assessment of tumor stiffness (time frame: Baseline to 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05990244, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.