Actively Recruiting
Minimally INvasive Colon Cancer Surgery Through IMmunomics and Optical Mapping of the Sentinel Lymph Node.
Led by University Hospital, Ghent · Updated on 2024-09-19
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
K
Kom Op Tegen Kanker
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of laparoscopic fluorescent imaging to detect the sentinel lymph node (SLN) during surgery in patients with colon cancer. This study aims to explore the immune and microenvironmental changes in normal and affected lymph nodes and link these changes to their anatomical locations. The goal is to improve the understanding and surgical management of colon cancer by mapping lymph node involvement precisely. The study involves injecting a tracer called ICG-nanocoll, which is indocyanine green combined with human albumin particles, into the tissue near the tumor during laparoscopic surgery. After injection, near-infrared fluorescence imaging is used to identify and mark the sentinel lymph nodes. This procedure helps surgeons visually map the nodes during the operation to assess tumor involvement. Participants will undergo surgery with the tracer injection and imaging. Researchers will monitor the tumor status of the sentinel lymph node and other lymph nodes for up to one month after surgery. Additionally, immunological markers will be studied for up to 12 months after surgery. The study includes regular laboratory tests and clinical evaluations to track outcomes and safety over time, with the entire participation lasting up to a year after the operation.
CONDITIONS
Brief Title
Minimally INvasive Colon Cancer Surgery Through IMmunomics and Optical Mapping of the Sentinel Lymph Node.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Proven adenocarcinoma of the colon
- Clinically node negative (stage II) non-metastatic colon cancer
- Locally resectable disease
- Adequate mental ability to understand treatment and give consent
- Serum creatinine 64 1.5 mg/dl or GFR 7 60 mL/min/1.73 m2
- Serum total bilirubin 64 1.5 mg/dl except Gilbert's disease
- Platelet count > 100,000/bcl
- Hemoglobin > 9g/dl
- Neutrophil granulocytes > 1,500/ml
- INR 64 2
- No alcohol or drug abuse
- Not enrolled in other conflicting trials
- No current chronic systemic immune therapy, chemotherapy, or hormone therapy
- No severe organ insufficiency
- Not pregnant or breastfeeding
- Use of adequate contraception if fertile
- Provided written informed consent
You will not qualify if you...
- Node positive and/or metastatic disease
- Locally unresectable disease
- Medically unfit with Karnofsky index < 70%
- Allergy to iodides or products containing human albumin
- Pregnancy or breastfeeding
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo minimally invasive colon cancer surgery with injection of ICG-nanocoll tracer to identify and mark sentinel lymph nodes using near infrared fluorescence imaging.
1 surgical visit and immediate post-operative care
Duration - Up to 1 month after surgery
Participants are monitored for tumor status of sentinel lymph nodes and other lymph nodes up to 1 month after surgery.
Approximately 3 to 4 follow-up visits
Duration - Up to 12 months after surgery
Participants are monitored for immunological markers for up to 12 months after surgery.
Periodic visits over 12 months
Trial Site Locations
Total: 1 location
1
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
Research Team
W
Wim Ceelen
S
Sarah Cosyns
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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