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

Asan Medical Center

Status: Enrolling

Conditions: Adult Glioblastoma

Treatments: Device: Diffusion weighted MRI; Device: 3 Tesla magnetic resonance imaging; Device: Chemical exchange saturation transfer MRI; Device: Dynamic susceptibility contrast MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT02613988

AsanMCHSKim_01

Details and patient eligibility

About

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.

Full description

The standard care of patients with glioblastoma is concomitant chemoradiation and adjuvant temozolomide. Allowing for assessment of tumor therapy prior to treatment completion is important to select patients most likely to benefit from alternative treatment option. Multimodal advanced MR imaging- contrast-enhanced T1 weighted imaging, diffusion-weighted imaging, chemical exchange saturation transfer imaging, and perfusion imaging on 3T enables quantitative assessment of treatment response. Quantifying changes in advanced MR imaging techniques would allow predict outcome for early and long-term treatment response and survival in glioblastomas.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

MR imaging and standard treatment

Other group

Description:

Patients with glioblastoma undergo 3-Tesla magnetic resonance imaging to measure tumor protein content (using CEST-MRI), cellularity (using DW-MRI), and perfusion (using DCE-MRI and DSC-MRI with IV administration of gadolinium-containing contrast agent) at pre-CCRT; 4 weeks after completion of the CCRT; and every 2 or 3 months during the adjuvant temozolomide therapy.

Treatment:

Device: Dynamic susceptibility contrast MRI

Device: Chemical exchange saturation transfer MRI

Device: 3 Tesla magnetic resonance imaging

Device: Diffusion weighted MRI