Clinical Trial: 3T MRI Biomarkers of Glioma Treatment Response
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Early Detection of Glioma Treatment Response Using MRI-Based Biomarkers
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: Vanderbilt-Ingram Cancer Center
Current Primary Outcome: Best Response [ Time Frame: On‐treatment date to date of disease progression (up to 12 weeks) ]
Original Primary Outcome: Best Response [ Time Frame: On‐treatment date to date of disease progression (assess up to 12 weeks) ]
Current Secondary Outcome: Progression Free Survival (PFS) [ Time Frame: On‐study date to lesser of date of progression or date of death from any cause (assessed at 6 months) ]
Original Secondary Outcome: Same as current
Information By: Vanderbilt-Ingram Cancer Center
Dates:
Date Received: November 15, 2013
Date Started: May 2012
Date Completion:
Last Updated: April 13, 2017
Last Verified: April 2017