MR Elastography in Intracranial Lesions: Feasibility & Accuracy

Active, not recruiting

• Conditions: Brain Neoplasms

• Registration Number: NCT06916715
• Lead Sponsor: Shengjing Hospital

Brief 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. 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 512 brain tumor patients (May 2017-December 2024) 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 meningioma, pituitary adenoma, glioma, craniopharyngioma, germ cell tumor, chordoma, metastatic tumor, acoustic neuroma, and lymphoma, 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 512 patients with brain tumors between May 2017 and December 2024. 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 Timeline

• Study Start: 2017-05-09
• Primary Completion: 2024-12-09
• Study First Submitted: 2025-03-31
• Study First Submitted QC: 2025-03-31
• Status Verified: 2025-04
• Study First Posted: 2025-04-08
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Study Completion: 2025-12-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 512

Inclusion Criteria

• All patients undergoing intracranial space-occupying lesions resection surgery are eligible for inclusion in the study.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy of Magnetic Resonance Elastography (MRE) for Brain Tumor Grading	Data collection period: May 2017-December 2024 (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	Data analysis period: May 2017-December 2024.	Determine the successful application rate of MRE in acquiring valid imaging data for intracranial space-occupying lesions, analyzing technical feasibility and influencing factors.

Trial Locations

Locations (1)

Shengjing Hospital; 🇨🇳 Shenyang,, Liaoning, China