Radiogenomic and Prognosis Analysis in Glioma

Glioma Clinical Trial

Official title:

Prospective Observational Study of Imaging-based Prediction for Genomic Mutations and Prognosis in Glioma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04122521
• Other study ID #: AsanMCHSKim_03
• Status: Recruiting
• Start date: January 12, 2020
• Est. completion date: February 2021

Study information

• Verified date: February 2020
• Source: Asan Medical Center
• Contact: Ji Eun Park, MD PhD
• Phone: +82 2 3010 1505
• Email: jieunp[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Glioma

Intervention

Diagnostic Test:
• MRI
MRI

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression	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.	Through study completion, an average of 2 years
Secondary	Genomics including IDH mutation, 1p19q codeletion, MGMT methylation and EGFR mutation status	Proportion of positive IDH mutation, 1p19q codeletion, MGMT methylation and EGFR mutation in percentage (%)	2 months
Secondary	Progression free survival	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.	Through study completion, an average of 3 years