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NCT Number: NCT06916715

MR Elastography in Intracranial Lesions: Feasibility & Accuracy

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.

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Key information

Age range

7 year–83 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shengjing Hospital

Shenyang, Liaoning, 110000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study title

Feasibility and Diagnostic Accuracy of Magnetic Resonance Elastography in Intracranial Space-Occupying Lesions

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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