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

Not Applicable

Recruiting

• Conditions: Colon Cancer; Sentinel Lymph Node
• Interventions: Other: ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll)

• Registration Number: NCT03779009
• Lead Sponsor: University Ghent

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2018-12-13
• Study First Posted: 2018-12-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tracer injection	ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll)	-

Primary Outcome Measures

Name	Time	Method
Tumor status of the sentinel lymph node (SLN) and other lymph nodes (LN's)	up to 1 month after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Immunological markers	up to 12 months after surgery	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.

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Gent, Belgium