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

Primary Purpose

Colon Cancer, Sentinel Lymph Node

Status

Recruiting

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

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

About this trial

This is an interventional other trial for Colon Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Ghent University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tracer injection

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03779009

First Posted

December 12, 2018

Last Updated

March 14, 2023

Sponsor

University Ghent

Collaborators

University Hospital, Ghent, Kom Op Tegen Kanker

1. Study Identification

Unique Protocol Identification Number

NCT03779009

Brief Title

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

Acronym

MINIMAL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2018 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Ghent

Collaborators

University Hospital, Ghent, Kom Op Tegen Kanker

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer, Sentinel Lymph Node

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tracer injection

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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 Outcome Measure Information:

Title

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

Description

Time Frame

up to 1 month after surgery

Secondary Outcome Measure Information:

Title

Immunological markers

Description

Time Frame

up to 12 months after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wim Ceelen

Phone

+32(0)93326251

wim.ceelen@ugent.be

First Name & Middle Initial & Last Name or Official Title & Degree

Sarah Cosyns

Phone

+32(0)93321562

sarah.cosyns@ugent.be

Facility Information:

Facility Name

Ghent University Hospital

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wim Ceelen

Phone

+32(0)93326251

wim.ceelen@ugent.be

First Name & Middle Initial & Last Name & Degree

Sarah Cosyns

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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