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

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).

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wim Ceelen; Phone Number: +32(0)93326251; Email: wim.ceelen@ugent.be
• Study Contact Backup: Name: Sarah Cosyns; Phone Number: +32(0)93321562; Email: sarah.cosyns@ugent.be

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital
    • Contact: Wim Ceelen; Phone Number: +32(0)93326251; Email: wim.ceelen@ugent.be
    • Sub-Investigator: Sarah Cosyns

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tracer injection	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	up to 12 months after surgery

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: University Hospital, Ghent; Kom Op Tegen Kanker

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: EC/2017/1356

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No