Radiogenomic and Prognosis Analysis in Glioma

• Conditions: Glioma
• Interventions: Diagnostic Test: MRI

• Registration Number: NCT04122521
• Lead Sponsor: Asan Medical Center

Brief Summary

This study aims to evaluate whether MRI can be used to predict genomics and prognosis in glioma. Given the profound prognostic significance of genetic mutations seen in glioma, there have been increasing attempts to correlate imaging characteristics with genetic, mutational and expression patterns. To be able to predict genomics and prognosis based on imaging alone will prove useful in patients with involvement of glioma in delicate areas of the brain and better reflect tumor and molecular heterogeneity.

Detailed Description

Previous studies have proposed certain imaging characteristics correlating with genetic, molecular and expression patterns. Advanced imaging provides additional clues but no studies have examined its added value particularly in a prospective setting. The investigator's aim to evaluate preoperative MRI for patients suspected of glioma to predict IDH mutation, 1p19q codeletion, MGMT methylation and EGFR mutation status using imaging characteristics such as margin, patterns of contrast enhancement and edema as well as diffusion and perfusion characteristics. This will be confirmed pathologically and further correlated with patients' long term outcome.

Study Timeline

• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-09
• Study First Posted: 2019-10-10
• Study Start: 2020-01-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-07
• Primary Completion: 2021-02
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Patients suspected of glioma undergoing MRI examination prior to surgery
• MRI including advanced imaging such as cerebral blood volume, apparent diffusion coefficient and amide proton transfer imaging
• Signed informed consent

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Exclusion Criteria

• Pathologic confirmation as tumors other than glioma
• Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulates, electronic infusion pumps, etc), because such devices may be displaced or malfunction
• Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Glioma	MRI	Patients suspected of glioma

Primary Outcome Measures

Name	Time	Method
Time to progression	Through study completion, an average of 2 years	The response was determined by a modification of the response assessment in neuro-oncology (RANO) criteria that combined the image assessment, neurologic evaluation and assessment of steroid use.

Secondary Outcome Measures

Name	Time	Method
Genomics including IDH mutation, 1p19q codeletion, MGMT methylation and EGFR mutation status	2 months	Proportion of positive IDH mutation, 1p19q codeletion, MGMT methylation and EGFR mutation in percentage (%)
Progression free survival	Through study completion, an average of 3 years	Estimated probable duration of life without disease progression, from on-study date to earlier progression date or date of death from any cause, using the Kaplan-Meier method with censoring. The response was determined by a modification of the RANO criteria that combined the image assessment, neurologic evaluation and assessment of steroid use.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of