Status:
RECRUITING
NIR-Fluorescence Guided Surgical Resection of Neoadjuvant Treated Localized Pancreatic Cancer Using SGM-101
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Dutch Cancer Society
Surgimab
Conditions:
Pancreas Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 curat...
Detailed Description
Pancreatic cancer is a lethal cancer type and is continuously rising as cause of cancer-related death in the Western World. Despite advances in surgical and systemic treatment, the 5-year overall surv...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- 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 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.
- EXCLUSION CRITERIA
- 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 the following criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
March 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05984810
Start Date
March 18 2024
End Date
December 1 2026
Last Update
April 4 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Leiden University Medical Center
Leiden, Netherlands, 2300RC