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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
High resolution structural imaging (contrast-enhanced T1-weighted image, T2-weighted image, Fluid-attenuated inversion recovery)
Amide proton transfer-weighted image
diffusion-weighted image with b value 0, 1000, and 3000
Asan Medical Center
Seoul, South Korea
RECRUITINGDiagnostic Performance of Response Rate
The response was determined by a modification of the RANO criteria that combined the image assessment, neurologic evaluation and assessment of steroid use. Clinical and radiologic assessments were carried out at pre-CCRT; 4 weeks after completion of the CCRT; and every 2 or 3 months during the adjuvant TMZ therapy. Complete Response (CR) was defined as complete disappearance on MR of all enhancing tumor; Partial Response (PR) was defined as greater than or equal to 50% reduction in tumor size on MR by bi-dimensional measurement; Pseudoprogression was defined when there was a decrease or stabilization of the contrast-enhancing lesions for a minimum of six months and combined with no change in treatment/ or a increase in contrast-enhancing lesion on the first subsequent follow-up MR image, as long as it stabilized on the second follow-up and there was no need for treatment change. Responder = CR+PR+Pseudoprogression, Non-responder = Progression.
Time frame: 6 month
Progression Free Survival (PFS)
Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring. Disease progression is defined under Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as \>=20% increase in sum of longest diameters (LD) of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
Time frame: On-study date to lesser of date of progression or date of death from any cause (assessed at 6 months)
Quantitative changes to tumor protein content and tumor acidosis
Amide proton transfer asymmetry (APTasym, %) from Chemical Exchange Saturation Transfer (CEST) Amine proton transfer asymmetry (AmPTasym %) from CEST
Time frame: Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT
Quantitative changes to tumor cellularity
Apparent diffusion coefficient (ADC, mm2/s) from Diffusion weighted MRI
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dual echo EPI sequence
Time frame: Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT
Quantitative changes to tumor perfusion using dynamic susceptibility contrast MRI
Normalized Cerebral blood volume (CBV, %) from dynamic susceptibility contrast (DSC)-MRI
Time frame: Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT
Quantitative changes to tumor perfusion using dynamic contrast enhancement MRI
Initial area-under-the-curve (IAUC) from dynamic contrast enhancement (DCE)-MRI
Time frame: Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT