WHENII - Early Response Evaluation With 18F-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose(FDG)- Positrons Emissions Tomography(PET)/CT and Liquid Biopsy in Patients With NSCLC (Non Small Cell Lung Cancer)
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Observation of changes in circulating tumor DNA during first treatment.
研究概览
简要总结
Response evaluation with FDG-PET and free circulating DNA in patients with inoperable lung cancer of non small cell type during first treatment with chemotherapy or immunotherapy.
详细描述
Interventional study of patients with inoperable lung cancer of non small cell type undergoing 1st treatment of either chemotherapy or immunotherapy. Patients are evaluated with FDG-PET/ct and blood analyses og circulating tumor DNA and cancer markers to determine early response.
PET-CT are preceded before and after treatment is given;
- day 0 before treatment,
- day 2 after treatment and
- day 21 just before second treatment. At every FDG-PET/ct scan blood are examined for circulating tumor DNA (ctDNA) and potentially cancer markers by White genome sequencing. In total 3 PET-CT scans and 4 blood samples are performed. The result are compared with the standard CT scan after 2-3 cycles of treatment. Blood analyses are repeated after 2-3 cycles to observe any changes.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with non-small cell lung cancer (NSCLC) who is about to start treatment with chemo- or immune therapy. No prior treatment of the one given.
- •Measurable decease according to RECIST criteria
- •Age > 18 years
- •Performance status 0-2 (0-1 for immunotherapy)
- •Understands and reads danish
排除标准
- •Poor performance status
- •Secondary active cancer
- •Pregnancy
- •Dysregulated diabetes mellitus
研究组 & 干预措施
All patients
Both patients receiving chemotherapy and immunotherapy are observed during the same intervention with PET/CT and liquid biopsy. No primary comparison are made between the groups.
干预措施: PET/CT (Device)
结局指标
主要结局
Observation of changes in circulating tumor DNA during first treatment.
时间窗: 3 months
Measure changes in the amount of free circulating DNA
Observation of changes in metabolism in cancer cells during first treatment with chemotherapy or immunotherapy.
时间窗: 3 months
Measure changes in standardized uptake value (SUV) in tumorcells by FDG-PET.
次要结局
未报告次要终点
研究者
heidi ryssel
Doctor
Rigshospitalet, Denmark