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

NCT03779009 | Recruiting

• 1 other identifier: EC/2017/1356
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Colon Cancer; Sentinel Lymph Node

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Immunological markers

  up to 12 months after surgery

Study Arms (1)

Tracer injection

EXPERIMENTAL

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

Interventions

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.

Tracer injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy
• Absence of any severe organ insufficiency
• No pregnancy or breast feeding

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Kom Op Tegen Kanker: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Wim Ceelen

CONTACT

+32(0)93326251; wim.ceelen@ugent.be

Sarah Cosyns

CONTACT

+32(0)93321562; sarah.cosyns@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 19, 2018
• Study Start: March 1, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)