Comparative Study of the Hypoxia Measured in FAZA and F-miso TEP/CT Scan in Patients With Non-small Cell Lung Cancer at the Time of Diagnosis : Correlation With Immunohistochemistry
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Comparison of hypoxia with FAZA and F-Miso tracer
研究概览
简要总结
The purpose of the study is to compare the intratumoral biodistribution of FAZA and F-miso in patients with non-small cell lung cancer and correlate the results of PET scans with immunohistochemistry.
详细描述
The aim of the study is to compare the biodistribution of the two tracers specific for hypoxia in patients with non-small cell lung cancer.
Two PET scans will be performed with FAZA and F-Miso tracers. The time between these twi PET scans will be 24 hours.
another 24 hours after the late PET scan, the surgery will be done and a piece of tumor will be collected.
Piece of tumor will be analysed by immunohistochemistry for hypoxia markers.
The results of immunohistochemistry will be correlated with the biodistribution of the two tracers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Male or female
- •More than 18 years old
- •Patient with non-small cell lung cancer (histologically proved)
- •PS inferior or equal to 1 (good general state)
- •Patient must have surgery for their non-small cell lung cancer
- •Stage of tumor Superior or equal to 2a without metastasis
- •Tumoral fixation with 18-FDG-PET superior to mediastinal background noise
- •Written inform consent
排除标准
- •Histology other than primitive non-small cell lung cancer
- •In situ form at the histological study
- •Patient without evaluable target
- •No fixation on the pretherapeutic FDG-PET scan
- •PS Superior or equal to 2
- •neoplastic disease (less than 2 years or progressive)
- •Pregnant woman or child-bearing
- •Patient Under guardianship or curators
结局指标
主要结局
Comparison of hypoxia with FAZA and F-Miso tracer
时间窗: one year
SUV max, SUV mean and SUV peak were calculated for FAZA PET and Fmiso PET and will be correlated with results of immunohistochemistry
次要结局
- disease-free survival(one year)
- overall survival(one year)