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

Colon Cancer Clinical Trial

— MINIMAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03779009
• Other study ID #: EC/2017/1356
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: University Hospital, Ghent
• Contact: Wim Ceelen
• Phone: +32(0)93326251
• Email: wim.ceelen[@]ugent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Sentinel Lymph Node

Intervention

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

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Gent

Sponsors (3)

Lead Sponsor	Collaborator
University Ghent	Kom Op Tegen Kanker, University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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