NCT05984810RecruitingPhase 2
NIR-Fluorescence Guided Surgical Resection of Neoadjuvant Treated Localized Pancreatic Cancer Using SGM-101
A Performance Study of SGM-101, a Fluorochrome-labeled Anti-carcinoembryonic Antigen Monoclonal Antibody for Fluorescence-guided Imaging to Determine Local Extent and Resectability During Surgical Resection of Pancreatic Ductal Adenocarcinoma After Neoadjuvant Treatment
Source: ClinicalTrials.gov · Last updated 4 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 25 Jul 2023
- Start date
- 18 Mar 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Leiden University Medical Center
- Diseases
- Pancreatic cancer
- NCT number
- NCT05984810
- EudraCT number
- 2023-000026-28
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 18 Mar 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous administration of SGM-101;
- Previous administration of SGM-101;
Other illness
- History of clinically significant anaphylactic reactions;
- 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:
- Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
Other
- Part A: To be eligible for conclusion in this study, patients must meet none of the following criteria:
- Pregnant women, or women giving breast feeding;
- Pregnant women, or women giving breast feeding;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Leiden University Medical Center Coordinator of this site? Confirm its status | Leiden | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.