RecruitingNot ApplicableNCT03779009

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

Sponsor

University Hospital, Ghent

Enrollment

70 participants

Start Date

Mar 1, 2018

Study Type

INTERVENTIONAL

Conditions

Sentinel Lymph Node Colon Cancer

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria18

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 Criteria4

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)

Interventions

OTHERICG-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.