This pilot clinical trial studies advanced magnetic resonance imaging (MRI) techniques in measuring treatment response in patients with high-grade glioma. New diagnostic procedures, such as advanced MRI techniques at 3 Tesla, may be more effective than standard MRI in measuring treatment response in patients receiving treatment for high-grade gliomas.
PRIMARY OBJECTIVES: I. To correlate treatment-induced changes in quantitative MRI-based biomarkers-specifically, those sensitive to tumor protein content (amide proton transfer asymmetry \[APTasym\] from chemical exchange saturation transfer \[CEST\]), cellularity (apparent diffusion coefficient \[ADC\] from diffusion-weighted imaging \[DWI\]), and blood flow (volume transfer constant \[K\^trans\] from dynamic contrast-enhanced \[DCE\]; cerebral blood flow \[CBF\] from dynamic susceptibility contrast \[DSC\])-with treatment-induced changes in tumor size, measured via standard anatomic MRI. II. To correlate treatment-induced changes in the above quantitative MRI endpoints with patient progression-free survival (PFS). OUTLINE: Patients undergo measurement of tumor protein content using CEST-MRI, cellularity using DWI-MRI, and blood flow using DCE-MRI and DSC-MRI within 2 weeks of treatment and at 2 and 4 weeks after initiation of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
7
3-Tesla MRI is a multiparametric imaging exam that includes MR pulse sequences for CEST-MRI, DW-MRI, DCE-MRI, and DSC-MRI
Undergo CEST-MRI
Undergo DWI-MRI
Undergo DCE-MRI
Undergo DSC-MRI
Gadolinium-containing paramagnetic contrast agent (Magnevist®; Berlex Lab, Wayne, New Jersey) in delivered via intravenous (IV) infusion to achieve DCE and DSC contrast
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Best Response
Number of patients in each response category, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, summarized as follows for target lesion criteria: complete response (CR),disappearance of target lesions; partial response (PR), \>=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), \>=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR\>PR\>SD\>PD.
Time frame: On-treatment date to date of disease progression (up to 12 weeks)
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 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)
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