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

Trial ID: NCT05984810

Interventional - Phase 2 - Recruiting

Pancreatic carcinoma has a dismal prognosis at time of diagnosis, due to late onset of clinical symptoms, patients present with advance disease. Complete surgical resection is the only potential curative treatment, however only a small percentage is eligible for upfront total surgical resection due to extension into anatomical related important vascular structures. Neoadjuvant chemo(radio)therapy has become the standard treatment modality for non-primary resectable disease (borderline resectable and locally advanced pancreatic cancer (LAPC)), where subsequent downstaging can make identification of the primary tumor more challenging during surgery. Near-infrared (NIR) fluorescence imaging can aid surgeons by providing real-time visualization of tumors, suspect lymph nodes and vital structures during surgery. Additional intra-operative feedback could possibly reduce the frequency of positive resection margins and increase complete removal of locally spread tumor and involved lymph nodes and could thereby improve patient outcomes as well as overall survival. SGM-101 is a targeted NIR-fluorophore, with specific binding capacity for Carcino Embryonic Antigen (CEA) which is overexpressed on tumor cells in the gastro-intestinal tract, including pancreatic cancer.

Conditions

• Pancreas Adenocarcinoma

Interventions

• Fluorescence-guided surgery using CEA-targeted fluorophore SGM-101

Eligibility

Inclusion criteria

• Part A: To be eligible for inclusion in this study, patients must meet all of the following criteria:
• 1. Signed informed consent prior to any study-mandated procedure;
• 2. Patients aged over 18 years old;
• 3. Has the ability to communicate well with the Investigator in the Dutch/English language and willing to comply with the study restrictions.
• 4. 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:
• 1. Signed informed consent prior to any study-mandated procedure;
• 2. Patients aged over 18 years old;
• 3. 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:
• 1. History of clinically significant anaphylactic reactions;
• 2. Previous administration of SGM-101;
• 3. Pregnant women, or women giving breast feeding;
• 4. 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:
• 1. Previous administration of SGM-101;
• 2. Pregnant women, or women giving breast feeding;
• 3. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.

Sponsor

Leiden University Medical Center, Dutch Cancer Society, Surgimab

Source: ClinicalTrials.gov

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