Dynamic FDG-PET/CT Response During Chemoradiation for NSCLC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- maximum FDG uptake (SUVmax)
研究概览
简要总结
A prospective observational study to determine the prognostic value of the timing of 50% reduction in metabolic activity (T50) during CCRT for NSCLC for treatment outcome (PFS).
详细描述
This is a single-centre observational study. Patients with proven locally advanced NSCLC will be treated with concurrent chemoradiotherapy according to the standard clinical protocol of the NKI-AVL. During treatment, the biological behaviour of the tumour will be monitored with serial quantitative FDG (fluorodeoxyglucose) PET/CT scans. From these images, the time during treatment where a 50% reduction in FDG uptake relative to day 1 is reached (T50) will be derived. The T50 of progression-free surviving patients will be compared with that of relapsed or deceased patients, in order to find a value that predicts early treatment failure. An additional FDG PET/CT scan at the same day as regular follow up CT scan will be made, two months after treatment, to have a baseline after treatment for follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Cytologically or histologically proven NSCLC
- •T2-4 N0-3 M0 disease (stage II or III, inoperable)
- •Scheduled for standard concurrent chemoradiation
- •Primary tumour minimal diameter 3 cm
- •Primary tumour SUVmax > 5 on routine diagnostic pre-treatment FDG (Fludeoxyglucose) PET/CT
- •WHO performance 0-1
- •Written informed consent according to GCP (Good Clinical Practice) and national regulations
排除标准
- •Age < 18 years, incapacitated subjects
- •Pregnant or lactating women
- •Diabetes mellitus requiring medication
- •Participation in dose escalation studies
- •Other neoplasms in the last 3 years, with metastases
研究组 & 干预措施
Low dose FDG PET/CT 5x
Stage II/III NSCLC will undergo a Low dose FDG PET/CT 5x during treatment (CCRT).
干预措施: Low dose FDG PET/CT 5 x. (Other)
结局指标
主要结局
maximum FDG uptake (SUVmax)
时间窗: 1 Year
• A main study parameter is the maximum FDG uptake (SUVmax (maximum Standardized Uptake Value)) at the location of the primary tumour, as determined at multiple days during treatment (with a maximum of five time points per patient), expressed as T50 for response evaluation.
次要结局
- SUVmax during the first two weeks of treatment, indicating inflammatory response.(First Two weeks of treatment)
- Progression free survival(1 Year)
- SUVmax in the two weeks prior to treatment, indicating progression(Two weeks prior to treatment)