Fluorescence-guided surgery for pancreatic cancer
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
This study is testing a special imaging technique to help surgeons see pancreatic tumors better during surgery for patients who have had treatment before their operation.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Drugs / interventions | SurgiMab |
| Locations | 1 site (Leiden) |
| Trial ID | NCT05984810 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of near-infrared (NIR) fluorescence imaging to assist in the surgical resection of pancreatic cancer in patients who have undergone neoadjuvant therapy. By utilizing a CEA-targeted fluorophore called SGM-101, surgeons aim to improve the visualization of tumors and lymph nodes during surgery, potentially leading to better surgical outcomes. The study focuses on patients with borderline resectable or locally advanced pancreatic cancer, where traditional imaging may not accurately represent the tumor's status post-therapy. The goal is to reduce positive resection margins and enhance the complete removal of tumors.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with neoadjuvant treated borderline resectable or locally advanced pancreatic cancer scheduled for surgical resection.
Not a fit: Patients with a history of clinically significant anaphylactic reactions or those not eligible for surgical resection may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes and survival rates for patients with pancreatic cancer.
How similar studies have performed: Other studies utilizing fluorescence-guided surgery have shown promising results, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Leiden
- Leiden University Medical Center — Leiden, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.