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

Study Overview
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Brief Summary
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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).

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

Conditions
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Colon Cancer, Sentinel Lymph Node

Intervention / Treatment
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* Other: ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tracer injection<br> | Other: ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll)<br>* Under laparoscopic control, 2.0 ml of ICG-nanocoll will be injected into the subserosa at four quadrants around the tumor. Directly after injection, near infrared (NIR) fluorescence images (Olympus, Tokyo, Japan) will be acquired. SLNs will be identified and marked.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor status of the sentinel lymph node (SLN) and other lymph nodes (LN's) | All LN in the resection specimen will be collected, mapped, and labeled. The SLN is defined as fluorescent hotspot that appears after injection of the tracer. Standard H&E staining will be performed on LN sections and all mapped LN (including the SLN) will be analyzed for their tumor status. | up to 1 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological markers | Single cell suspensions will be prepared from all LN (including the SLNs) and the primary tumor. Cell suspensions will be analyzed for cytotoxic CD8+ CD45RO+T cells, CD4+ T helper cells, dendritic cell subsets (DC), natural killer (NK) cells, tumor-associated macrophages (TAM), and myeloid-derived suppressor cells (MDSCs) by multicolor fluorescence-activated cell sorting (FACS)-based immuno-panels. FACS is technique to detect and measure physical and chemical characteristics of a population of cells and provides quantifiable data. | up to 12 months after surgery |