跳至主要内容
临床试验/NCT06916715
NCT06916715进行中(未招募)不适用

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

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 626 人开始时间: 2017年5月9日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
626
试验地点
1
主要终点
Diagnostic Accuracy of Magnetic Resonance Elastography (MRE) for Brain Tumor Grading

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
7 Years 至 83 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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)

排除标准

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

研究组 & 干预措施

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.

结局指标

主要结局

Diagnostic Accuracy of Magnetic Resonance Elastography (MRE) for Brain Tumor Grading

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu Shi

Professor

Shengjing Hospital

研究点 (1)

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