Clinical trial NCT02613988: Advanced MR Imaging as Predictor of Treatment Response in Newly Diagnosed Glioblastomas
Official title: Early Response Assessment Using on 3T Advanced MR Imaging as Predictor of Long-term Treatment Response in Newly Diagnosed Glioblastomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adult Glioblastoma
Keywords: Glioblastoma
MRI
standard treatment
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic Performance of Response Rate
timeFrame: 6 month
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: On-study date to lesser of date of progression or date of death from any cause (assessed at 6 months)
measure: Quantitative changes to tumor protein content and tumor acidosis
timeFrame: Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT
measure: Quantitative changes to tumor cellularity
timeFrame: Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT
measure: Quantitative changes to tumor perfusion using dynamic susceptibility contrast MRI
timeFrame: Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT
measure: Quantitative changes to tumor perfusion using dynamic contrast enhancement MRI
timeFrame: Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Ho Sung Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Galban CJ, Chenevert TL, Meyer CR, Tsien C, Lawrence TS, Hamstra DA, Junck L, Sundgren PC, Johnson TD, Galban S, Sebolt-Leopold JS, Rehemtulla A, Ross BD. Prospective analysis of parametric response map-derived MRI biomarkers: identification of early and distinct glioma response patterns not predicted by standard radiographic assessment. Clin Cancer Res. 2011 Jul 15;17(14):4751-60. doi: 10.1158/1078-0432.CCR-10-2098. Epub 2011 Apr 28.
citation: Park JE, Kim HS, Goh MJ, Kim SJ, Kim JH. Pseudoprogression in Patients with Glioblastoma: Assessment by Using Volume-weighted Voxel-based Multiparametric Clustering of MR Imaging Data in an Independent Test Set. Radiology. 2015 Jun;275(3):792-802. doi: 10.1148/radiol.14141414. Epub 2015 Jan 21.
citation: Park JE, Kim HS, Park KJ, Kim SJ, Kim JH, Smith SA. Pre- and Posttreatment Glioma: Comparison of Amide Proton Transfer Imaging with MR Spectroscopy for Biomarkers of Tumor Proliferation. Radiology. 2016 Feb;278(2):514-23. doi: 10.1148/radiol.2015142979. Epub 2015 Aug 19.