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

Ghent University Hospital (UZ)

Status: Enrolling

Conditions: Sentinel Lymph Node; Colon Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03779009

EC/2017/1356

Details and patient eligibility

About

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).

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Tracer injection

Experimental group

Treatment:

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