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.

Conditions

Pancreatic tumor

Brief summary

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.

Detailed description

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

Related papers

No related papers found yet.

Interventions

DRUGSGM-101

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed