MR Elastography in Intracranial Lesions: Feasibility & Accuracy

NCT06916715 | Active Not Recruiting DMC

• 1 other identifier: Shengjing_Brain
• Study Type: observational
• Target: 626
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Brain Neoplasms

Keywords

Magnetic resonance elastography

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Data analysis period: May 2017-December 2026.

Study Arms (1)

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.

Eligibility Criteria

• Age: 7 Years - 83 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110000, China

Location

Related Publications (2)

• 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.

  PMID: 26162026 BACKGROUND

• 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.

  PMID: 34185076 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Yu Shi, MD

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

• Anhua Wu, MD

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

• Wen Cheng, MD

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 8, 2025
• Study Start: May 9, 2017
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): December 9, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)