Early Response Assessment Using on 3T Advanced MR Imaging as Predictor of Long-term Treatment Response in Newly Diagnosed Glioblastomas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Diagnostic Performance of Response Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Diagnostic Performance of Response Rate
时间窗: 6 month
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.
次要结局
- Quantitative changes to tumor protein content and tumor acidosis(Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT)
- Quantitative changes to tumor perfusion using dynamic susceptibility contrast MRI(Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT)
- Progression Free Survival (PFS)(On-study date to lesser of date of progression or date of death from any cause (assessed at 6 months))
- Quantitative changes to tumor cellularity(Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT)
- Quantitative changes to tumor perfusion using dynamic contrast enhancement MRI(Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT)
研究者
Ho Sung Kim
Associate Professor
Asan Medical Center