Correlazione Dell'Imaging Metabolico Con l'Espressione Dei Marcatori Immunitari Nei Pazienti Con NSCLC Candidati All'Immunoterapia.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Correlate the tumor expression of immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy.
研究概览
简要总结
The purpose of the present study is to prospectively investigate the correlation between the metabolic parameters on FDG-PET before and during immunotherapy treatment with the immune infiltrate and other tissue or circulating markers in a NSCLC patients candidate to immunotherapy.
详细描述
This is an interventional prospective study without medication lasting 36 months, including an estimated period of 18 months for the enrolment and max 18 months of follow-up. All consecutive patients affected by NSCLC and referred for immunotherapy with the anti-PD-1 agent nivolumab, or other checkpoint inhibitors that may become available in the future, will be prospectively enrolled. The study cohort will consist of 40 patients.
All patients will undergo the following steps: 1) selection based on eligibility criteria and informed consent; 2) baseline examinations (ceCT and 18F-FDG PET/CT); 3) tumor biopsy and blood sampling; 4) Immunotherapy with check-point inhibitors; 5) response evaluation after 8 weeks of treatment (ceCT and 18F-FDG PET/CT) and second blood sampling; 6) 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
- Diagnostic
- 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
- •patients with pathological diagnosis of NSCLC eligible for immunotherapy;
- •obtained informed consent.
排除标准
- •age <18 years;
- •pregnancy or breast-feeding.
结局指标
主要结局
Correlate the tumor expression of immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy.
时间窗: Baseline
Standardized uptake value
次要结局
- Evaluate other tissue or circulating markers in patients with NSCLC before and 8 weeks after the first administration of immunotherapy.(8 weeks after treatment)
- Correlate immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy.(Baseline)
- Tumor expression of immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy.(Before treatment)
- Quantify the variation of metabolic parameters on FDG-PET in patients with NSCLC before and 8 weeks after the first administration of immunotherapy.(After 8 weeks of treatment)
- Evaluate the variation of metabolic parameters on FDG-PET in patients with NSCLC before and 8 weeks after the first administration of immunotherapy.(After 8 weeks of treatment)