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Recruiting

NCT Number: NCT03779009

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

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Location status: Recruiting

Location contact

Sarah Cosyns

CONTACT

Wim Ceelen

CONTACT

[email protected]

+32(0)93326251

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other

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.

Primary outcomes

  1. Tumor status of the sentinel lymph node (SLN) and other lymph nodes (LN's)

    Time frame: 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 outcomes

  1. Immunological markers

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Cosyns

CONTACT

[email protected]

+32(0)93321562

Wim Ceelen

CONTACT

[email protected]

+32(0)93326251

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Kom Op Tegen Kanker

Registry information

Acronym: MINIMAL

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2018
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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