NCT00759382Unknown不适用
Prognostic Role of Primary Non Small Cell Lung Carcinoma Standardized F18-FDG Uptake Values (SUV and TLG) Measured With F18-fluorodeoxyglucose Positron Emission Tomography (F18-FDG-PET): a Non Interventional Study.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 340
- 试验地点
- 6
- 主要终点
- Survival
研究概览
简要总结
The primary aim of this non interventional study is to assess the independent prognostic role on overall survival of primary tumour 18F-FDG uptake value (SUVmax) measured on 18fluorodeoxyglucose positron emission tomography (18F-FDG-PET) in patients with non-metastatic non-small cell lung cancers treated with curative intent, taking into account the other conventional prognostic factors (performance status, age, sex, disease stage).
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
- •Pathologically demonstrated NSCLC
- •Stage I-III treated by curative treatment by surgery with or without chemotherapy (induction or adjuvant) or by chemoradiotherapy
- •Inoperable patients treated by exclusive radiotherapy
- •A whole-body (skull base to mid thighs) FDG-PET or a combined FDG-PET/CT on a dedicated machine, performed before any anticancer treatment
- •FDG-PET or combined FDG-PET/CT has to be previously standardised according to the procedure described in appendix IV
- •Written informed consent
- •Accessibility to follow-up
- •Age > 18 years
排除标准
- •Prior anticancer treatment (surgery, radiotherapy or chemotherapy)
- •Stage IV NSCLC
- •A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval)
- •Uncontrolled diabetes mellitus (fast glycaemia above 130 mg/dl)
- •Pregnancy and lactating woman
- •Unavailability to send a copy of the PET or PET-CT (DICOM format) to the data centre
结局指标
主要结局
Survival
时间窗: Survival will be dated from the date of PET scan
次要结局
- Progression-free survival(Period between the date of PET scan and the date of first progression or death)
研究者
研究点 (6)
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