Actively Recruiting

Phase 2
Age: 18Years +
All Genders
Healthy Volunteers
NCT05984810

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

Led by Leiden University Medical Center · Updated on 2024-04-04

20

Participants Needed

1

Research Sites

141 weeks

Total Duration

On this page

Sponsors

L

Leiden University Medical Center

Lead Sponsor

D

Dutch Cancer Society

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

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Trial Site Locations

Total: 1 location

1

Leiden University Medical Center

Leiden, Netherlands, 2300RC

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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