NIR-Fluorescence Guided Surgical Resection of Neoadjuvant Treated Localized Pancreatic Cancer Using SGM-101 (FLUOPANC-II)
Pancreas Adenocarcinoma

About this trial
This is an interventional treatment trial for Pancreas Adenocarcinoma focused on measuring Fluorescence Guided Surgery, Pancreatic Ductal Adenocarcinoma, Neoadjuvant therapy, Near-Infrared (NIR) Fluorescence imaging, CEA
Eligibility Criteria
INCLUSION CRITERIA Part A: To be eligible for inclusion in this study, patients must meet all of the following criteria: 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 Part B: To be eligible for inclusion in this study, healthy volunteers must meet all of the following criteria: 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. EXCLUSION CRITERIA Part A: To be eligible for conclusion in this study, patients must meet none of the following criteria: 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 well-being or the study objectives. Part B: To be eligible for conclusion in this study, healthy volunteers must meet none of the following criteria: 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 well-being or the study objectives.
Sites / Locations
- Leiden University Medical Center
Arms of the Study
Arm 1
Experimental
10mg, administered 3-5 days before surgery
Drug: SGM-101 Intravenous single injection of the targeted NIR fluorophore SGM-101. This targeted 700nm fluorophore developed by SurgiMab S.A.S., Montpellier, France. Device: Intraoperative near-infrared fluorescence imaging Intraoperative imaging will be performed with the following CE-marked near-infrared (NIR) fluorescence imaging system: Quest Spectrum imaging platform (v2/3.0). With a NIR-imaging system a potential fluorescent signal of the tumor can be evaluated. Furthermore, the Quest Spectrum platform will also be used for evaluation of ex-vivo fluorescence of resected tissue on the back table (Back table imaging) and pathology department (ex-vivo imaging), which shall be performed during and after every procedure.