Minimally invasive surgery for colon cancer using advanced imaging techniques
Minimally INvasive Colon Cancer Surgery Through IMmunomics and Optical Mapping of the Sentinel Lymph Node.
This study is testing a new imaging technique during colon cancer surgery to see if it can help doctors find important lymph nodes more easily in patients who have early-stage cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Ghent) |
| Trial ID | NCT03779009 on ClinicalTrials.gov |
What this trial studies
This project explores the feasibility of using laparoscopic fluorescent imaging to detect the sentinel lymph node (SLN) during surgery for colon cancer patients. It aims to correlate immunological and microenvironmental changes in lymph nodes with their anatomical locations. The intervention involves the use of indocyanine green coupled to human albumin colloidal particles to enhance imaging during the procedure. The study focuses on patients with clinically node-negative, non-metastatic colon cancer who are eligible for surgical resection.
Who should consider this trial
Good fit: Ideal candidates are adults with proven adenocarcinoma of the colon that is clinically node negative and locally resectable.
Not a fit: Patients with node-positive colon cancer or those undergoing concurrent systemic therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more precise surgical techniques and improved outcomes for colon cancer patients.
How similar studies have performed: Other studies utilizing similar imaging techniques have shown promise, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Tumor type: proven adenocarcinoma of the colon * Extent of disease (AJCC 7th edition): clinically node negative (stage II) non-metastatic colon cancer * Locally resectable disease * Adequate mental faculty, allowing to understand the proposed treatment protocol and provide informed consent * Laboratory data * Serum creatinine ≤ 1.5 mg/dl or a calculated GFR ≥ 60 mL/min/1.73 m2 * Serum total bilirubin ≤ 1.5 mg/dl, except for known Gilbert's disease * Platelet count \> 100,000/µl * Hemoglobin \> 9g/dl * Neutrophil granulocytes \> 1,500/ml * International Normalized Ratio (INR) ≤ 2 * Absence of alcohol and/or drug abuse * No inclusion in other clinical trials interfering with the study protocol * No concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy * Absence of any severe organ insufficiency * No pregnancy or breast feeding * Adequate contraception in fertile patients * Written informed consent Exclusion Criteria: * Node positive and/or metastatic disease * Locally unresectable disease * Medically unfit patients (Karnofsky index \< 70%) * Allergies to any of the procedural substances (allergy to iodides, hypersensitivity to products containing human albumin)
Where this trial is running
Ghent
- Ghent University Hospital — Ghent, Belgium (Recruiting)
Study contacts
- Study coordinator: Wim Ceelen
- Email: wim.ceelen@ugent.be
- Phone: +32(0)93326251
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.