MINIONS - Patient-specific Microstructural and radIobiological Model for persoNalised External Beam radiatION Therapy in Localised tumourS
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
- Improvement of personalized tumor-models
研究概览
简要总结
The study will include the prospective acquisition of optimized MR imaging data of prostate and breast patients treated with radiotherapy (RT).
Within the prospective study, biological specimens from patients undergoing in-room biopsy before RT, will be collected. Histological evaluation and cell culture (and organoid preparation) will be conducted, and samples/organoids will be irradiated with RT for biological validation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- 未提供
排除标准
- •Exclusion criteria for prostate patients:
- •Nodule involvement and metastasis (cN1 and/or cM1)
- •Concomitant inflammation of the intestine
- •Significant systemic diseases or ongoing oral anticoagulant therapy
- •Non-compliance of dose constraints in the treatment plan
- •Previous invasive cancer, unless the patient has had no disease for at least 3 years
- •Mental disorders that cannot ensure valid informed consent
- •Exclusion criteria for breast patients:
- •Histology other than non-special histotype and non-epithelial tumors (sarcoma, lymphoma)
- •High-risk mutation carrier patients
- •Bilateral breast cancer
- •synchronous distant metastases
- •Neoadjuvant therapy
- •autoimmune connective tissue diseases
- •previous radiotherapy to the chest
- •Mental disorders that cannot ensure valid informed consent
- •No previous thoracic radiotherapy
结局指标
主要结局
Improvement of personalized tumor-models
时间窗: 3 years
Improvement of the implemented models, by relying on advanced agnetic Resonance Imaging (MRI) data acquired prospectively
Generation of in-silico tumor model
时间窗: 1 year
generate an in-silico tumour model able to describe tumour microstructure and its interaction with the radiation beam
Personalization of the tumour model with patient-specific MR imaging data
时间窗: 1 year
personalize the tumour model implemented in A1 with patient-specific MR imaging data for tumour characterization and treatment outcome prediction, relying on retrospective data
Evaluation of tumor model in describing the in-vivo microstructural and radiobiological characteristics
时间窗: 3 years
The evaluation of the implemented in-silico tumour model in describing the in-vivo microstructural and radiobiological characteristics, by collecting histopathological features and irradiating primary cell cultures.
次要结局
未报告次要终点