NCT05984810 NIR-Fluorescence Guided Surgical Resection of Neoadjuvant Treated Localized Pancreatic Cancer Using SGM-101
| NCT ID | NCT05984810 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Leiden University Medical Center |
| Condition | Pancreas Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-03-18 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2024-03-18 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT05984810 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreas Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05984810 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05984810 currently recruiting?
Yes, NCT05984810 is actively recruiting participants. Visit ClinicalTrials.gov or contact Leiden University Medical Center to inquire about joining.
Where is the NCT05984810 trial being conducted?
This trial is being conducted at Leiden, Netherlands.
Who is sponsoring the NCT05984810 clinical trial?
NCT05984810 is sponsored by Leiden University Medical Center. The trial plans to enroll 20 participants.