Prospective Observational Study of Imaging-based Prediction for Genomic Mutations and Prognosis in Glioma
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Asan Medical Center
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Time to progression
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Time to progression
Time Frame: 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 Outcomes
- Genomics including IDH mutation, 1p19q codeletion, MGMT methylation and EGFR mutation status(2 months)
- Progression free survival(Through study completion, an average of 3 years)
Investigators
Ho Sung Kim
Professor
Asan Medical Center