F Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) for the Delivery of Adaptive Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 271
- 试验地点
- 2
- 主要终点
- The number of subjects with benefit from an intra-treatment PET-CT
研究概览
简要总结
The purpose of this study is to determine the benefit of using positron emission tomography (PET) in addition to the standard (computed tomography) CT to plan radiation therapy for cancer treatment. The information from the PET-CT may allow the investigators to change the radiation plan or the delivery of the radiation to the tumor/tumor site such as the total dose of radiation or the size of the area to receive further radiation. Presently the use of PET scans to adjust radiation therapy during radiation treatment is not standard of care and is being investigated in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically (histologically or cytologically) proven diagnosis of carcinoma
- •Patients with local or regional nodal disease are eligible.
- •Zubrod Performance Status 0, 1, or
- •Negative serum pregnancy test for women of child bearing potential
- •Patient must sign study-specific informed consent prior to study entry.
排除标准
- •No gross disease visible on imaging at the start of radiotherapy
- •Contraindication to PET
- •Complete response by PET achieved with pre-radiation therapy treatment (surgery or chemotherapy)
- •Breast feeding
结局指标
主要结局
The number of subjects with benefit from an intra-treatment PET-CT
时间窗: 3 years
This benefit lies in the potential to adapt the treatment plan based on an intratreatment PET-CT. This may also be of significant prognostic utility, at an early enough time point to potentially alter treatment accordingly.
次要结局
- Measure overall survival (OS)(3 years)
- Measure late toxicities(3 years)
- Measure acute toxicities(During radiation therapy and within 30 days of the last radiation treatment)
- Locoregional control.(Day of intra treatment PET-CT/ approx 2-4 hours)
- Freedom from distant metastases(3 years)