- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06916715
MR Elastography in Intracranial Lesions: Feasibility & Accuracy
Feasibility and Diagnostic Accuracy of Magnetic Resonance Elastography in Intracranial Space-Occupying Lesions
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Liaoning
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Shenyang, Liaoning, China, 110000
- Shengjing Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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).
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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.
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Data collection period: May 2017-Sepember 2025 (retrospective analysis of existing MRE and clinical data).
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Success Rate of Magnetic Resonance Elastography (MRE) in Assessing Intracranial Space-Occupying Lesions
Time Frame: Data analysis period: May 2017-December 2026.
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Determine the successful application rate of MRE in acquiring valid imaging data for intracranial space-occupying lesions, analyzing technical feasibility and influencing factors.
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Data analysis period: May 2017-December 2026.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yu Shi, MD, Shengjing Hospital
- Principal Investigator: Anhua Wu, MD, Shengjing Hospital
- Principal Investigator: Wen Cheng, MD, Shengjing Hospital
Publications and helpful links
General Publications
- Louis 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Shengjing_Brain
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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