Brain NeoplasmsNCT06916715
MR Elastography in Intracranial Lesions: Feasibility & Accuracy
An observational study of Brain Neoplasms, run by Shengjing Hospital at 1 site in China.
Trial summary
Brain tumors, despite their relatively low incidence among cancers, are associated with high morbidity and mortality due to the brain's complexity. Biopsy, the gold standard for tumor grading, is limited by invasiveness, costs, and sampling issues. Read more about this study
- Who is it for?
- Ages 7 to 83 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Neoplasms
- How many people
- 626 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2017to 9 Dec 2026
- Phase
- Observational
- 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 7 to 83 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This retrospective study enrolled 626 patients diagnosed with intracranial space-occupying lesions who underwent magnetic resonance elastography (MRE) at Shengjing Hospital between May 2017 and September 2025. All participants had available MRE data, met inclusion criteria (scheduled for intracranial space-occupying lesion resection surgery and provided written informed consent), and covered diverse intracranial space-occupying lesions , serving as the cohort for MRE-based space-occupying lesions characteristic analysis.
Who may be able to join
- Tumor diameter > 2 cm
- MR elastography performed within one week before surgery
- Patients were excluded if they had:
- incomplete MRI or MRE data
- A history of brain trauma, brain tumors, or surgery
- Received chemotherapy, radiotherapy, or hormone therapy for any reason before surgery
- Tumors that could not be assigned grades according to the fifth edition of the WHO Classification of CNS (WHO CNS5)
- MRE examinations with suboptimal wave image quality (e.g., motion artifacts or inadequate wave amplitude)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Diagnostic Accuracy of Magnetic Resonance Elastography in Intracranial Space-Occupying Lesions
Brain tumors, despite their relatively low incidence among cancers, are associated with high morbidity and mortality due to the brain's complexity. Biopsy, the gold standard for tumor grading, is limited by invasiveness, costs, and sampling issues. Conventional MR imaging lacks sensitivity to differentiating tumor grades, while magnetic resonance elastography (MRE) offers non-invasive assessment potential. This retrospective study reviewed MRE data from 626 brain tumor patients (May 2017-September 2025) to evaluate MRE's diagnostic performance, success rate in tumor grading, and clinical reliability, aiming to advance its role in non-invasive brain tumor assessment.
Read the detailed description
Despite their relatively low incidence among all cancers, brain tumors are associated with substantial morbidity and mortality, attributed to the brain's intricate structure and critical physiological roles. Pathologically categorized into metastases to the CNS; meningiomas; gliomas, glioneuronal tumors, and neuronal tumors; tumors of the sellar region; cranial and paraspinal nerve tumors; hematolymphoid tumors; mesenchymal, non-meningothelial tumors; embryonal tumors; germ cell tumors; and choroid plexus tumors, these neoplasms undergo a complex, multi-stage evolution-encompassing initial cellular alterations, tumorigenesis, progression, and potential metastasis. Their oncogenesis is intricately linked to dysregulated cell differentiation during embryonic development, where lower differentiation grades typically correlate with higher malignancy. Clinically, brain tumors manifest as elevated intracranial pressure, neurological and cognitive deficits, and epileptic seizures.
The curability of brain tumors depends on tumor type, grading, and therapeutic strategies. While benign tumors often achieve complete remission through surgical resection, malignant tumors require sophisticated multimodal therapies. Although biopsy serves as the gold standard for tumor grading, its invasive nature, high cost, potential complications, poor patient tolerance, and susceptibility to sampling bias and interpretive subjectivity limit its applicability for frequent monitoring. In this context, non-invasive imaging modalities-such as magnetic resonance elastography (MRE)-capable of longitudinal assessment of lesioned brain tissue, provide invaluable clinical insights, guiding emerging therapeutic interventions aimed at decelerating or halting progression to terminal brain tumors.
Conventional magnetic resonance (MR) imaging effectively visualizes tumors via morphological changes; however, these traditional techniques demonstrate limited sensitivity to differentiating tumor grades. Emerging evidence highlights MRE's potential in tumor grading and diagnosis. Despite the increasing clinical adoption of brain MRE, its widespread implementation remains restricted. Therefore, rigorous quality control of MRE acquisitions is essential to ensure result reproducibility and reliability, while identifying root causes of suboptimal outcomes.
This retrospective study analyzed MRE findings from 626 patients with brain tumors between May 2017 and September 2025. By evaluating MRE's diagnostic efficacy, success rate in tumor grading, and clinical reliability, the research addresses critical gaps in non-invasive brain tumor assessment, contributing to the advancement of evidence-based neuro-oncological imaging practices.
- Conditions
- Brain Neoplasms
- Keywords
- Magnetic resonance elastography
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intracranial Neoplastic and Non-Neoplastic Lesions | This group encompasses patients with intracranial neoplastic lesions (including low-grade tumors, WHO 1-2; and high-grade tumors, WHO 3-4) and non-neoplastic lesions. It involves retrospective analysis of magnetic resonance elastography (MRE) data to assess the feasibility and diagnostic accuracy of MRE in identifying and differentiating various intracranial pathologies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of Magnetic Resonance Elastography (MRE) for Brain Tumor Grading
Evaluate diagnostic performance of MRE in differentiating brain tumor grades (e.g., WHO grades), using pathological results as the gold standard. Metrics include sensitivity, specificity, and overall diagnostic accuracy.
Measured: Data collection period: May 2017-Sepember 2025 (retrospective analysis of existing MRE and clinical data).
Success Rate of Magnetic Resonance Elastography (MRE) in Assessing Intracranial Space-Occupying Lesions
Determine the successful application rate of MRE in acquiring valid imaging data for intracranial space-occupying lesions, analyzing technical feasibility and influencing factors.
Measured: Data analysis period: May 2017-December 2026.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start9 May 2017
- Primary completion25 Sep 2026 (estimated)
- Study completion9 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 626 participants (actual)
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 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916715
- Sponsor's protocol ID
- Shengjing_Brain
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yin M, Glaser KJ, Talwalkar JA, Chen J, Manduca A, Ehman RL. Hepatic MR Elastography: Clinical Performance in a Series of 1377 Consecutive Examinations. Radiology. 2016 Jan;278(1):114-24. doi: 10.1148/radiol.2015142141. Epub 2015 Jul 8.
PubMed 26162026Louis DN, Perry A, Wesseling P, Brat DJ, Cree IA, Figarella-Branger D, Hawkins C, Ng HK, Pfister SM, Reifenberger G, Soffietti R, von Deimling A, Ellison DW. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol. 2021 Aug 2;23(8):1231-1251. doi: 10.1093/neuonc/noab106.
PubMed 34185076
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Diagnostic Accuracy of Magnetic Resonance Elastography in Intracranial Space-Occupying Lesions
- ClinicalTrials.gov ID
- NCT06916715
- Acronym / sponsor ID
- Shengjing_Brain
- Conditions
- Brain Neoplasms
- Keywords
- Magnetic resonance elastography
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 626 participants (actual)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 9 May 2017 (actual)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 9 Dec 2026 (estimated)
- First posted
- 8 Apr 2025 (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.
Brain tumors, despite their relatively low incidence among cancers, are associated with high morbidity and mortality due to the brain's complexity. Biopsy, the gold standard for tumor grading, is limited by invasiveness, costs, and sampling issues. Conventional MR imaging lacks sensitivity to differentiating tumor grades, while magnetic resonance elastography (MRE) offers non-invasive assessment potential. This retrospective study reviewed MRE data from 626 brain tumor patients (May 2017-September 2025) to evaluate MRE's diagnostic performance, success rate in tumor grading, and clinical reliability, aiming to advance its role in non-invasive brain tumor assessment.
Detailed description
Despite their relatively low incidence among all cancers, brain tumors are associated with substantial morbidity and mortality, attributed to the brain's intricate structure and critical physiological roles. Pathologically categorized into metastases to the CNS; meningiomas; gliomas, glioneuronal tumors, and neuronal tumors; tumors of the sellar region; cranial and paraspinal nerve tumors; hematolymphoid tumors; mesenchymal, non-meningothelial tumors; embryonal tumors; germ cell tumors; and choroid plexus tumors, these neoplasms undergo a complex, multi-stage evolution-encompassing initial cellular alterations, tumorigenesis, progression, and potential metastasis. Their oncogenesis is intricately linked to dysregulated cell differentiation during embryonic development, where lower differentiation grades typically correlate with higher malignancy. Clinically, brain tumors manifest as elevated intracranial pressure, neurological and cognitive deficits, and epileptic seizures.
The curability of brain tumors depends on tumor type, grading, and therapeutic strategies. While benign tumors often achieve complete remission through surgical resection, malignant tumors require sophisticated multimodal therapies. Although biopsy serves as the gold standard for tumor grading, its invasive nature, high cost, potential complications, poor patient tolerance, and susceptibility to sampling bias and interpretive subjectivity limit its applicability for frequent monitoring. In this context, non-invasive imaging modalities-such as magnetic resonance elastography (MRE)-capable of longitudinal assessment of lesioned brain tissue, provide invaluable clinical insights, guiding emerging therapeutic interventions aimed at decelerating or halting progression to terminal brain tumors.
Conventional magnetic resonance (MR) imaging effectively visualizes tumors via morphological changes; however, these traditional techniques demonstrate limited sensitivity to differentiating tumor grades. Emerging evidence highlights MRE's potential in tumor grading and diagnosis. Despite the increasing clinical adoption of brain MRE, its widespread implementation remains restricted. Therefore, rigorous quality control of MRE acquisitions is essential to ensure result reproducibility and reliability, while identifying root causes of suboptimal outcomes.
This retrospective study analyzed MRE findings from 626 patients with brain tumors between May 2017 and September 2025. By evaluating MRE's diagnostic efficacy, success rate in tumor grading, and clinical reliability, the research addresses critical gaps in non-invasive brain tumor assessment, contributing to the advancement of evidence-based neuro-oncological imaging practices.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracranial Neoplastic and Non-Neoplastic Lesions | – | –This group encompasses patients with intracranial neoplastic lesions (including low-grade tumors, WHO 1-2; and high-grade tumors, WHO 3-4) and non-neoplastic lesions. It involves retrospective analysis of magnetic resonance elastography (MRE) data to assess the feasibility and diagnostic accuracy of MRE in identifying and differentiating various intracranial pathologies. |
Who may qualify
- Ages
- 7 to 83 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This retrospective study enrolled 626 patients diagnosed with intracranial space-occupying lesions who underwent magnetic resonance elastography (MRE) at Shengjing Hospital between May 2017 and September 2025. All participants had available MRE data, met inclusion criteria (scheduled for intracranial space-occupying lesion resection surgery and provided written informed consent), and covered diverse intracranial space-occupying lesions , serving as the cohort for MRE-based space-occupying lesions characteristic analysis.
Key inclusion criteria (8 listed)
- Tumor diameter > 2 cm
- MR elastography performed within one week before surgery
- incomplete MRI or MRE data
- A history of brain trauma, brain tumors, or surgery
- Received chemotherapy, radiotherapy, or hormone therapy for any reason before surgery
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Accuracy of Magnetic Resonance Elastography (MRE) for Brain Tumor Grading
Time frame: Data collection period: May 2017-Sepember 2025 (retrospective analysis of existing MRE and clinical data).
Evaluate diagnostic performance of MRE in differentiating brain tumor grades (e.g., WHO grades), using pathological results as the gold standard. Metrics include sensitivity, specificity, and overall diagnostic accuracy.
Success Rate of Magnetic Resonance Elastography (MRE) in Assessing Intracranial Space-Occupying Lesions
Time frame: Data analysis period: May 2017-December 2026.
Determine the successful application rate of MRE in acquiring valid imaging data for intracranial space-occupying lesions, analyzing technical feasibility and influencing factors.
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 30 Apr 2026.
- Background: PubMed 26162026Yin M, Glaser KJ, Talwalkar JA, Chen J, Manduca A, Ehman RL. Hepatic MR Elastography: Clinical Performance in a Series of 1377 Consecutive Examinations. Radiology. 2016 Jan;278(1):114-24. doi: 10.1148/radiol.2015142141. Epub 2015 Jul 8.
- Background: PubMed 34185076Louis DN, Perry A, Wesseling P, Brat DJ, Cree IA, Figarella-Branger D, Hawkins C, Ng HK, Pfister SM, Reifenberger G, Soffietti R, von Deimling A, Ellison DW. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol. 2021 Aug 2;23(8):1231-1251. doi: 10.1093/neuonc/noab106.
- 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. This study is not recruiting at the moment.
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?
An observational study of Brain Neoplasms, 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 8 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of Magnetic Resonance Elastography (MRE) for Brain Tumor Grading (time frame: Data collection period: May 2017-Sepember 2025 (retrospective analysis of existing MRE and clinical data).). The study lists 2 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 NCT06916715, which also lists 2 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 30 Apr 2026.