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Radiogenomic and Prognosis Analysis in Glioma

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04122521
Enrollment
62
Registered
2019-10-10
Start date
2020-01-12
Completion date
2021-02-28
Last updated
2020-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma

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.

Interventions

DIAGNOSTIC_TESTMRI

MRI

Sponsors

Asan Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Time to progressionThrough study completion, an average of 2 yearsThe 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

MeasureTime frameDescription
Genomics including IDH mutation, 1p19q codeletion, MGMT methylation and EGFR mutation status2 monthsProportion of positive IDH mutation, 1p19q codeletion, MGMT methylation and EGFR mutation in percentage (%)
Progression free survivalThrough study completion, an average of 3 yearsEstimated 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.

Countries

South Korea

Contacts

Primary ContactJi Eun Park, MD PhD
jieunp@gmail.com+82 2 3010 1505
Backup ContactMin Jae Kim, MD
manzae.kim@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026