Image-derived Prediction of Response to Chemo-radiation in Patients With Glioblastoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of predicted response
研究概览
简要总结
This study seeks to investigate if advanced image-analysis of diagnostic scans, can be used to predict how aggressive brain tumors (glioblastoma) respond to standard chemo- and radiation treatment.
详细描述
Generally, response prediction models seeks to predict time to an event, e.g. time-to-progression and/or overall survival. The aim of this study is to explore the feasibility of establishing an individualized response model, that, based on several morphologic, physiologic and metabolic parameters extracted from computed tomography (CT), positron emission tomography (PET) and magnetic resonance imaging (MRI), is able to predict the tumor response at the level of an imaging voxel, using machine learning techniques.
Imaging modalities include MRI, PET/CT with 18F-fluroethyltyrosine (18F-FET), and PET/MRI with 64Cu-diacetyl-bis(N4-methylthiosemicarbazone) (64Cu-ATSM).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Histologically confirmed, primary supratentorial glioblastoma (WHO grade IV).
排除标准
- •No informed consent can be obtained
- •Inability to undergo MRI examination, due to metal implants, pacemaker etc.
- •Not eligible for Stupp-regimen
研究组 & 干预措施
Standard chemoradiotherapy
Group to receive 60 Gy radiotherapy in 30 fractions with concomitant and adjuvant temozolomide.
干预措施: Radiotherapy (Radiation)
Standard chemoradiotherapy
Group to receive 60 Gy radiotherapy in 30 fractions with concomitant and adjuvant temozolomide.
干预措施: Temozolomide (Drug)
结局指标
主要结局
Sensitivity and specificity of predicted response
时间窗: 3 months post radiotherapy
Tumor response is measured as contrast-enhancing tumor on T1-weighted MRI and by metabolic active tumor using 18F-fluroethyl-tyrosine (FET)-PET. Pre-treatment risk map is constructed using machine learning methods and compared to post-treatment scans.
次要结局
- DICE-similarity coefficient and percentage overlap of 64Cu-ATSM and contrast-enhanced T1-weighted MRI(3 months post radiotherapy)
- Correlation (volume and maximum values) between lactate and hypoxia(1 week before start of chemoradiotherapy)
研究者
Michael Lundemann Jensen
Ph.d.-fellow, M.Sc.
Rigshospitalet, Denmark