RecruitingNot ApplicableNCT02613988

Advanced MR Imaging as Predictor of Treatment Response in Newly Diagnosed Glioblastomas

Early Response Assessment Using on 3T Advanced MR Imaging as Predictor of Long-term Treatment Response in Newly Diagnosed Glioblastomas


Sponsor

Asan Medical Center

Enrollment

100 participants

Start Date

Jan 12, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial studies advanced MR imaging techniques in measuring early response of standard treatment may become predictors of long-term treatment response in patients with newly diagnosed glioblastomas.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Patients must have radiologically and histologically confirmed diagnosis of newly diagnosed glioblastoma
  • Patients must have measurable disease, defined as evident tumors with gadolinium enhancement on MRI that is measurable in at least one diameter
  • Life expectancy of greater than 3 months
  • Patients scheduled for standard therapy (6 weeks radiation treatment (RT) \~ 60 Gy, plus temozolomide 75 mg/m\^2 during 6 week RT, and followed routine monthly temozolomide therapy)
  • Ability to understand and the willingness to sign a written informed consent document; all patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines

Exclusion Criteria6

  • Patients who underwent complete resection
  • Patients with no evidence of measurable disease after surgery
  • Patients who have had chemotherapy or radiotherapy
  • Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, 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
  • For patients who have undergone surgical resection prior to joining the study, in whom baseline magnetic resonance (MR) images exhibit enough signal degradation (due to susceptibility artifact in the region of the surgical bed) such that the data are uninterpretable will be excluded

Interventions

DEVICE3 Tesla magnetic resonance imaging

High resolution structural imaging (contrast-enhanced T1-weighted image, T2-weighted image, Fluid-attenuated inversion recovery)

DEVICEChemical exchange saturation transfer MRI

Amide proton transfer-weighted image

DEVICEDiffusion weighted MRI

diffusion-weighted image with b value 0, 1000, and 3000

DEVICEDynamic susceptibility contrast MRI

dual echo EPI sequence


Locations(1)

Asan Medical Center

Seoul, South Korea

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NCT02613988