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

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ClinicalTrials.gov Identifier: NCT03779009
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : January 11, 2022
Sponsor:
Collaborators:
University Hospital, Ghent
Kom Op Tegen Kanker
Information provided by (Responsible Party):
GIHeelkunde, University Hospital, Ghent

Study Description
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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).

Condition or disease Intervention/treatment Phase
Colon Cancer Sentinel Lymph Node Other: ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Minimally INvasive Colon Cancer Surgery Through IMmunomics and Optical Mapping of the Sentinel Lymph Node.
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779009


Contacts
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Contact: Wim Ceelen +32(0)93326251 wim.ceelen@ugent.be
Contact: Sarah Cosyns +32(0)93321562 sarah.cosyns@ugent.be

Locations
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Belgium
Ghent University Hospital Recruiting
Gent, Belgium, 9000
Contact: Wim Ceelen    +32(0)93326251    wim.ceelen@ugent.be   
Sub-Investigator: Sarah Cosyns         
Sponsors and Collaborators
University Ghent
University Hospital, Ghent
Kom Op Tegen Kanker
More Information
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Responsible Party: GIHeelkunde, Principal investigator, University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03779009    
Other Study ID Numbers: EC/2017/1356
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases