Fluorescence-guided surgery for pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of near-infrared (NIR) fluorescence imaging to assist in the surgical resection of pancreatic cancer in patients who have undergone neoadjuvant therapy. By utilizing a CEA-targeted fluorophore called SGM-101, surgeons aim to improve the visualization of tumors and lymph nodes during surgery, potentially leading to better surgical outcomes. The study focuses on patients with borderline resectable or locally advanced pancreatic cancer, where traditional imaging may not accurately represent the tumor's status post-therapy. The goal is to reduce positive resection margins and enhance the complete removal of tumors.

Why it matters

Who can join: the full rules

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.

Where it's running

• Leiden University Medical Center
  Leiden, Netherlands Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.