Minimally INvasive Colon Cancer Surgery Through IMmunomics and Optical Mapping of the Sentinel Lymph Node.

Recruiting now · Not applicable

Conditions studied: Colon Cancer, Sentinel Lymph Node

In brief

The project investigates the feasibility of laparoscopic fluorescent imaging for the intraoperative detection of the sentinel lymph node (SLN) in colon cancer patients. In addition, the topology of immunological and microenvironmental changes in normal and invaded lymph nodes (LN's) will be correlated to the LN location (anatomical mapping).

Key facts

Study ID

NCT03779009

Run by

University Hospital, Ghent

People needed

70

Starts

2018-03-01

Expected to finish

2025-12-31

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Ghent University Hospital — Ghent, Belgium (enrolling)

Full record on ClinicalTrials.gov

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