RecruitingPhase 2NCT05984810

NIR-Fluorescence Guided Surgical Resection of Neoadjuvant Treated Localized Pancreatic Cancer Using SGM-101

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


Sponsor

Leiden University Medical Center

Enrollment

20 participants

Start Date

Mar 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a fluorescent dye called SGM-101, which is injected before surgery and attaches to cancer cells to make them glow under a special light (near-infrared light). This helps surgeons see cancer tissue more clearly during the removal of pancreatic cancer. **You may be eligible if (as a patient):** - You are 18 or older - You have borderline resectable or locally advanced pancreatic cancer that was treated with chemotherapy and/or radiation before surgery - You are scheduled for surgical removal of your pancreatic cancer - You can communicate in Dutch or English **You may be eligible if (as a healthy volunteer):** - You are 18 or older and can communicate in Dutch or English **You may NOT be eligible if:** - You have a history of severe allergic reactions - You have previously received SGM-101 - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREFluorescence-guided surgery using CEA-targeted fluorophore SGM-101

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


Locations(1)

Leiden University Medical Center

Leiden, Netherlands

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NCT05984810


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