A Technical Framework for Combining Multi-parametric Imaging With Advanced Modelling in Personalized Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- collect data from MRI acquisition
研究概览
简要总结
The study consists in the retrospective and prospective collection of imaging data (along with clinical information related to treatment) of skull-base chordoma patients treated with particle therapy, to derive imaging biomarkers which, integrated with advanced mathematical models, will allow predicting treatment outcome on a multi-scale basis.
详细描述
The study design consists of the retrospective collection of routinely-acquired data (CT, MRI and dose maps, along with relevant clinical information) and the prospective acquisition of optimized non-invasive MR imaging data, of skull-based chordoma patients treated with particle therapy (PT) at the National Center for Oncological Hadrontherapy (CNAO, Pavia, Italy).
This data will be stored in a proper repository under CNAO's control, shared with Politecnico di Milano through encrypted channels, and it will be used to implement mathematical models able to predict treatment outcome at different scales (macroscopic, microscopic and radiobiological).
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
- •Patients with histologically confirmed diagnosis of chordoma of the skull base
- •Particle therapy with curative intent
- •Karnofsky Performance status greater than or equal to 60
- •Patients with macroscopic disease detectable at pre-radiotherapy imaging
- •Patients undergoing PT with standardized treatment procedures
- •Patients who have signed the written informed consent for research
排除标准
- •Metastatic disease
- •Palliative treatment
- •Other malignancies with disease-free interval < 5 years (excepting pre- cancerous lesions)
- •Pregnancy
- •Simultaneous CHT or Immunotherapy
- •Extensive metal instrumentation/implants
- •Patients with autoimmune diseases (ADs) -including collagen-vascular (CVD) and inflammatory bowel (IBD)
结局指标
主要结局
collect data from MRI acquisition
时间窗: 1 year from the treatment provided in routine clinical setting
The prospective part of the study aims to collect data from MRI acquisition. It is not focused on patients treatment.
次要结局
未报告次要终点