MR Based Prediction of Molecular Pathology in Glioma Using Artificial Intelligence

Recruiting

• Conditions: Glioma

• Registration Number: NCT04217018
• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

Brief Summary

This registry aims to collect clinical, molecular and radiologic data including detailed clinical parameters, molecular pathology (1p/19q co-deletion, MGMT methylation, IDH and TERTp mutations, etc) and conventional/advanced/new MR sequences (T1, T1c, T2, FLAIR, ADC, DTI, PWI, etc) of patients with primary gliomas. By leveraging artificial intelligence, this registry will seek to construct and refine algorithms that able to predict molecular pathology or subgroups of gliomas.

Detailed Description

Non-invasive and precise prediction for molecular biomarkers such as 1p/19q co-deletion, MGMT methylation, IDH and TERTp mutations is challenging. With the development of artificial intelligence, much more potential lies in the preoperative conventional/advanced MR imaging (T1 weighted imaging, T2 weighted imaging, FLAIR, contrast-enhanced T1 weighted imaging, diffusion-weighted imaging, and perfusion imaging) could be excavated to aid prediction of molecular pathology of gliomas. The creation of a registry for primary glioma with detailed molecular pathology, radiological data and with sufficient sample size for deep learning (\>1000) provide considerable opportunities for personalized prediction of molecular pathology with non-invasiveness and precision.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2019-12-30
• Study First Submitted QC: 2019-12-31
• Study First Posted: 2020-01-03
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-05
• Last Update Posted: 2021-02-08
• Primary Completion: 2027-01-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Patients must have radiologically and histologically confirmed diagnosis of primary glioma
• Life expectancy of greater than 3 months
• Must receive tumor resection
• Signed informed consent

Exclusion Criteria

• No gliomas
• No sufficient amount of tumor tissues for detection of molecular pathology
• Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic devices
• Patients who are pregnant or breast feeding
• Patients who are suffered from severe systematic malfunctions

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUC of prediction performance	up to 10 years	AUC=sensitivity+specificity-1

Trial Locations

Locations (1)

Department of Neurosurgery, First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China