Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kom Op Tegen Kanker | OTHER |
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tracer injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll) | Other | 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. |
| 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 |
| 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. |
Not provided
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
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wim Ceelen | Contact | +32(0)93326251 | wim.ceelen@ugent.be | |
| Sarah Cosyns | Contact | +32(0)93321562 | sarah.cosyns@ugent.be |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Recruiting | Ghent | 9000 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| up to 12 months after surgery |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided