Recruiting PHASE2 Pancreas Adenocarcinoma

New treatment option for Pancreas Adenocarcinoma

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

ClinicalTrials.gov ID: NCT05984810

What this study is testing

What it's testing
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.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older. Healthy volunteers may be eligible.

You may be able to join if

  • Part A: To be eligible for inclusion in this study, patients must meet all of the following criteria:
  • Signed informed consent prior to any study-mandated procedure;
  • Patients aged over 18 years old;
  • Has the ability to communicate well with the Investigator in the Dutch/English language and willing to comply with the study restrictions.
  • Neoadjuvant treated (borderline) resectable or locally advanced pancreatic cancer scheduled for a surgical resection Part B: To be eligible for...

You likely can't join if

  • Part A: To be eligible for conclusion in this study, patients must meet none of the following criteria:
  • History of clinically significant anaphylactic reactions;
  • Previous administration of SGM-101;
  • Pregnant women, or women giving breast feeding;
  • Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives. Part B: To be eligible...
  • Previous administration of SGM-101;
See the full eligibility criteria
Who can join
  • Part A: To be eligible for inclusion in this study, patients must meet all of the following criteria:
  • Signed informed consent prior to any study-mandated procedure;
  • Patients aged over 18 years old;
  • Has the ability to communicate well with the Investigator in the Dutch/English language and willing to comply with the study restrictions.
  • 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...
  • Signed informed consent prior to any study-mandated procedure;
  • Patients aged over 18 years old;
  • Has the ability to communicate well with the Investigator in the Dutch/English language.
What rules you out
  • Part A: To be eligible for conclusion in this study, patients must meet none of the following criteria:
  • History of clinically significant anaphylactic reactions;
  • Previous administration of SGM-101;
  • Pregnant women, or women giving breast feeding;
  • 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...
  • Previous administration of SGM-101;
  • Pregnant women, or women giving breast feeding;
  • Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.

The study team makes the final eligibility decision.

Where it's taking place

  • Leiden, Netherlands

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Leiden, Netherlands. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.