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

RecruitingPhase 2Ages 18 Years - anyAllLeiden University Medical Center
NCT05984810 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 positi

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📋 Eligibility rules (as published)
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.
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What it tests

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

1 site
Leiden University Medical Center
Leiden, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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