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

ConditionsColon Cancer Sentinel Lymph Node

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity Hospital, Ghent

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll)
Other intervention
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.

Treatment groups

70 Participants

are divided into 1 treatment group

Group A: Tracer injectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

up to 1 month after surgery

Secondary outcomes

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.

Time frame

up to 12 months after surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Ghent

Lead sponsor

Kom Op Tegen Kanker

Collaborator

Source ClinicalTrials.gov

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