Relationship Between Histopathological Features, Mutation Status, 18F-FDG PET/CT Radiomic Imaging Parameters as Well as Clinical Outcome in Patients With Treatment-naïve Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 主要终点
- Overall survival
研究概览
简要总结
Retrospective study in patients with therapy-naive non small cell lung carcinoma correlating presurgical F18-FDG-PET/CT imaging texture analysis data with postsurgical molecular pathology data and clinical patient outcome. Main aim is to identify pretherapeutic prognostic factors.
详细描述
Section 1:title and overview Title: Relationship between histopathological features, mutation status, 18F-FDG PET/CT radiomic imaging parameters as well as clinical outcome in patients with treatment-naïve non-small cell lung cancer(NSCLC).
Overview: Nowadays, the most increasingly rapid incidence rate among all tumors is lung cancer, which shows the highest morbidity rate. According to types of tumor cells, lung cancer is divided into two categories: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), the latter one includes squamous cell carcinoma, adenocacinoma and large cell carcinoma. The treatment methods are different according to TNM stages, mainly including surgical resection, focal therapy, radiotherapy, chemotherapy as well as immunotherapy. Despite improvements in drug development and treatments for NSCLC patients, five-year survival rates remain unacceptably low, because many patients present with advanced stages at initial diagnosis, with resistancy to therapy and with distant metastases. So an effective way to improve low survival rate is to increase diagnose rate in early stage, to predict whether patients will have benefits from the therapy and to determine probability of distant metastases. Positron emission tomography (PET)/ computed tomography (CT) plays an increasing clinical role in the management of many cancer patients, because it shows additional value in tumor staging, response assessment, prognosis and prediction of treatment response.
Currently, clinical predictive results of PET/CT imaging texture analyses have been obtained in a wide variety of malignancies, such as high-grade gliomas, breast cancer, lung cancer, metastatic colorectal cancer. Most of these studies have shown a significant relationship between PET/CT textural imaging data and patient's clinical outcome. More specifically, a number of NSCLC studies correlated diver gene and a series of PET/CT radiomic imaging parameters, in order to predict clinical outcomes of NSCLC patients.
However the results are somehow controversial and there is no standardization regarding calculation of PET/CT imaging parameters apart from standardized uptake values (SUV). Therefore additional studies are necessary.
Histopathological Lung Cancer Biomarkers:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Retrospective selection of both German cohort NSCLC patients with concomitant gene mutation results, CTCs accounting results and 18F-FDG PET/CT imaging data before lung tumor surgery (both German patient cohorts)
- •Retrsopective selection of Chinese NSCLC patients with concomitant gene mutation results, CTCs accounting results and 18F-FDG PET/CT imaging data before lung tumor surgery (Chinese patient collective)
排除标准
- •NSCLC patients with surgical resection of the target/primary tumor before 18F-FDG PET/CT scanning.
- •NSCLC patients with elevated blood glucose levels (> 150 mg/dl) immediately before 18F-FDG injection.
- •based on PET CT scanning no concomitant malignancies
结局指标
主要结局
Overall survival
时间窗: through study completion an average of 3 years after initial inclusion
Time to death based on clinical records
Progression free survival
时间窗: through study completion an average of 3 years after initial inclusion
Time to progression (RECIST) based on routine clinical CT imaging on a quarterly base
次要结局
未报告次要终点