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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04122521
Other study ID # AsanMCHSKim_03
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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