Clinical trial NCT06916715: MR Elastography in Intracranial Lesions: Feasibility & Accuracy
Official title: Feasibility and Diagnostic Accuracy of Magnetic Resonance Elastography in Intracranial Space-Occupying Lesions
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Brain Neoplasms
Keywords: Magnetic resonance elastography
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 512
Sex: ALL
Minimum age (years): 8
Maximum age (years): 83
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective study enrolled 512 patients diagnosed with intracranial space-occupying lesions who underwent magnetic resonance elastography (MRE) at Shengjing Hospital between May 2017 and December 2024. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic Accuracy of Magnetic Resonance Elastography (MRE) for Brain Tumor Grading
timeFrame: Data collection period: May 2017-December 2024 (retrospective analysis of existing MRE and clinical data).
measure: Success Rate of Magnetic Resonance Elastography (MRE) in Assessing Intracranial Space-Occupying Lesions
timeFrame: Data analysis period: May 2017-December 2024.
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang,
country: China
facility: Shengjing Hospital
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Yu Shi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shengjing Hospital
name: Anhua Wu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shengjing Hospital
name: Wen Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.