MR Elastography in Intracranial Lesions: Feasibility & Accuracy

NCT ID: NCT06916715

Last Updated: 2026-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

512 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-09

Study Completion Date

2026-12-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Brain Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

8 Years

Maximum Eligible Age

83 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shengjing Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yu Shi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yu Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Anhua Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Wen Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shengjing Hospital

Shenyang, Liaoning, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26162026 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34185076 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Shengjing_Brain

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

68Ga-P16-093 PET/CT Imaging in Glioma Patients
NCT05569434 UNKNOWN PHASE1/PHASE2