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) ]

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.


Original Primary Outcome: Best Response [ Time Frame: On‐treatment date to date of disease progression (assess up to 12 weeks) ]

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.


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) ]

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.


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