FLUOPANC II: A performance study of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody for fluorescence-guided imaging to determine local extent and resectability during surgical resection of pancreatic ductal adenocarcinoma after neoadjuvant treatment.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The ability to visualize the primary pancreatic tumor, the local tumor extent and resectability status, with adjacent lymph nodes and to visualize also potential distant metastatic lesions, using SGM-101 and dedicated NIR-imaging systems.
研究概览
简要总结
The ability to accurately visualize the primary pancreatic tumor, the local tumor extent and resectability status, with adjacent lymph nodes. As well as potential distant metastatic lesions, using SGM-101 and dedicated NIR-imaging systems. Visualization is measured using the tumor-to-background ratio (TBR) in in-vivo and ex-vivo setting. A tumor-tobackground ratio (TBR) of at least ≥1.5 provides sufficient contrast for adequate visualization / delineation and will therefore be used as cut-off value.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to any study-mandated procedure
- •Patients aged over 18 years old
- •Has the ability to communicate well with the Investigator in the Dutch/English language and willing to comply with the study restrictions
- •Neoadjuvant treated (borderline) resectable or locally advanced pancreatic cancer scheduled for a surgical resection
排除标准
- •History of clinically significant anaphylactic reactions
- •Previous administration of SGM-101
- •Pregnant women, or women giving breast feeding
- •Any condition that the investigator considers to be potentially jeopardizing the patient’s wellbeing or the study objectives
结局指标
主要结局
The ability to visualize the primary pancreatic tumor, the local tumor extent and resectability status, with adjacent lymph nodes and to visualize also potential distant metastatic lesions, using SGM-101 and dedicated NIR-imaging systems.
The ability to visualize the primary pancreatic tumor, the local tumor extent and resectability status, with adjacent lymph nodes and to visualize also potential distant metastatic lesions, using SGM-101 and dedicated NIR-imaging systems.
次要结局
- Concordance to pathology results with respect to the presence of cancer and the imaging assessment, based on fluorescent signal and the tumor status (incl. degree of CEA-expression) of biopsied or resected tissue. Measured by calculation of the sensitivity for accurate (tumor+) signal.
- Detection and quantification of circulating TiMas in samples of (porto) venous blood, lymph fluid and the lymphatic system obtained during surgery and follow-up
- Detection, quantification and characterization of tdEVs in portal-vein blood samples through flow cytometry, glycomics and cryo-electron microscopy. The data obtained will be correlated with clinical parameters
- Detection, quantification and characterization of tdEVs in peripheral blood samples through flow cytometry, glycomics and cryo-electron microscopy. The data obtained will be compared to data from portal-vein blood samples and correlated with clinical parameters
研究者
Clinical Research Center, dept. of Surgery
Scientific
Academisch Ziekenhuis Leiden