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
408 weeks
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
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
Official 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 according to AJCC 7th edition
- Locally resectable disease
- Adequate mental ability to understand the treatment and provide informed consent
- Laboratory values within limits: serum creatinine ≤ 1.5 mg/dl or GFR ≥ 60 mL/min/1.73 m2; serum total bilirubin ≤ 1.5 mg/dl (except Gilbert's disease); platelet count > 100,000/µl; hemoglobin > 9 g/dl; neutrophil granulocytes > 1,500/ml; INR ≤ 2
- No alcohol or drug abuse
- Not participating in other trials interfering with this study
- No current chronic systemic immune therapy, chemotherapy, or hormone therapy
- No severe organ insufficiency
- Not pregnant or breastfeeding
- Use of adequate contraception if fertile
- Written informed consent
You will not qualify if you...
- Node positive and/or metastatic disease
- Locally unresectable disease
- Medically unfit with Karnofsky index < 70%
- Allergies to any procedural substances, including iodides or products containing human albumin
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
Research Team
W
Wim Ceelen
CONTACT
S
Sarah Cosyns
CONTACT
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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