NCT01077869终止不适用
A Feasibility Study on the Use of F-18-FDG-PET and Optical Imaging in Evaluation of Radiation-induced Oral Mucositis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Feasibility of optical imaging in the evaluation of radiation-induced mucositis.
研究概览
简要总结
In this study, the feasibility of optical imaging and FDG-PET in the evaluation of radiation-induced mucositis will be evaluated.
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
- •Non-operated histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx (except the posterior wall) and lymph node metastases from the unknown primary tumor (CUP)
- •Stage T1-4; Tx N+ for the CUP
- •Multidisciplinary Group of Head and Neck Tumors at Ghent University Hospital decision of radical radiotherapy (±concurrent chemotherapy)
- •Informed consent obtained, signed and dated before specific protocol procedures.
排除标准
- •Age < 18 years
- •Pregnant or lactating women
- •Active infection or fistula in the oral/oropharyngeal mucosa
- •Previous cancer of the oral cavity and the oropharynx
- •Prior head-and-neck radiotherapy
- •Expectation of non-compliance with the study protocol
- •Known allergy for topical anesthetics (Xylocaïne)
结局指标
主要结局
Feasibility of optical imaging in the evaluation of radiation-induced mucositis.
时间窗: weekly assessment during 7 weeks
Feasibility of FDG-PET in the evaluation of radiation-induced mucositis.
时间窗: 2 weeks after radiotherapy
次要结局
未报告次要终点
研究者
研究点 (1)
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