Predicting Clinical Response and Outcome After Definitive Irradiation With MRI-Guided Adaptive Brachytherapy in Uterine Cervix Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of SUV-related tumor characteristics predicting recurrence
研究概览
简要总结
Observational study based on the routine clinical treatment and diagnostic course, to correlate imaging features with outcome objectives. Outcome will evaluated as clinical response to the standard treatment and as recurrence and survival in the follow up. The study hypothesis is that data extracted form FDG-PETCT used in the routine clinical practice can predict outcomes following standard treatment.
详细描述
This study will prospectively collect patients undergoing to the standard diagnostic and treatment protocol in Maastro Clinic. Any difference in the normal procedure will be adopted. The aim is to extrapolate form the PET images some features of the metabolic tumor activity to associate with different outcomes and tumor behaviours.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed cervix carcinoma (all subtypes)
- •Tumor Stages FIGO IB - IVA
- •Scheduled for primary curative radiotherapy (either or not combined with chemotherapy or hyperthermia)
- •pre treatment FDG PETCT
- •The patient is willing and capable to comply with study procedures
- •18 years or older
- •Written informed consent to the treatment
排除标准
- •Recent (< 3 months) myocardial infarction
- •Uncontrolled infectious disease
- •Pregnant or breast feeding and/or not willing to take adequate contraceptive measures during the study
- •Previous surgery to the Cervix
- •Previous radiation to the Cervix
结局指标
主要结局
Change of SUV-related tumor characteristics predicting recurrence
时间窗: Changes of parameters will be calculated on the pretreatment scan, than in average 2.5 months after the last radiotherapy session, than at least each 6 month for the first 2 years, eventually shortening the interval if clinically needed
* Standard Uptake Value Max (SUV- defined as the ratio of tissue radioactivity concentration (e.g. in MBq/kg=kBq/g) at time t, c(t), and the injected activity ( in MBq) at the time of injection (t=0) divided by the body weight in kg), * Metabolic Volume (MV) calculated in cc:volume of the evaluable metabolic activity on the PET scan calculated in a specific Region of Interest (ROI) semiautomatically delineated on the primary tumor in the uterine Cervix
次要结局
- Interobserver variability of Gross Tumor Volume (GTV) contours(GTV's will be delineated 2 weeks after the end of accrual)
- Change of SUV-related tumor characteristics predicting clinical overall response(Changes of parameters will be calculated on the pretreatment scan, and in average 2.5 months after the last radiotherapy session.)
- Radiomics Features(Radiomics features will be evaluated on the preteratment CT-fdg PET scan in average at least 2 weeks after the end of the accrual.)