uPAR-PET for Prognostication in Patients With Non-small Cell Lung Cancer, Malignant Pleural Mesothelioma and Large Cell Neuroendocrine Carcinoma of the Lung
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Study Ia: Overall survival (OS)
研究概览
简要总结
uPAR PET/CT as a prognostic marker in non-small cell lung cancer.
详细描述
Study I: uPAR PET/CT with 68Ga-NOTA-AE105 will be evaluated as a prognostic tool in patients with non-small cell lung cancer (NSCLC) (stage IV (Ia) operable disease (Ib)) by observer-blinded readings and compared to the prognostic performance of FDG PET/CT and prognostic biomarkers as uPAR.
Furthermore, uPAR PET/CT will be evaluated in a pilot study in patients with malignant pleural mesothelioma (MPM) (Study II) and large cell neuroendocrine carcinoma of the lung (LCNEC) (Study III) and correlated with immunohistochemical uPAR expression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically verified NSCLC (Study I)
- •Stage IV disease
- •Operable disease
- •The participants must be capable of understanding and giving full informed written consent
- •Histologically verified MPM (Study II)
- •The participants must be capable of understanding and giving full informed written consent
- •Histologically verified LCNEC (Study III)
- •The participants must be capable of understanding and giving full informed written consent
排除标准
- •Study I, II, III
- •Pregnancy
- •Lactation/breast feeding
- •Treatment with neoadjuvant chemotherapy
- •Weight above 140 kg
- •Allergy to 68Ga-NOTA-AE105
结局指标
主要结局
Study Ia: Overall survival (OS)
时间窗: Study Ia: OS is evaluated after clinical follow-up for 18 months (stage IV disease)
Study Ib: Overall survival (OS)
时间窗: Study Ib: OS is evaluated after clinical follow-up for 60 months (operable disease)
Study II and III: Uptake of 68Ga-NOTA-AE105 in primary tumor lesion (dichotomized +/-)
时间窗: Study II and III: Uptake of 68Ga-NOTA-AE105 is evaluated based on PET/CT scans performed within 1 hour post injection of 68Ga-NOTA-AE105
次要结局
- Study Ia: Progression free survival (PFS)(Study Ia: PFS is evaluated after clinical follow-up for 18 months (stage IV disease))
- Study Ib: Disease free survival (DFS)(Study Ib: DFS is evaluated after clinical follow-up for 60 months (operable disease))
研究者
Malene Martini Clausen
MD, PhD, postdoc
Rigshospitalet, Denmark