Status:
RECRUITING
Minimally INvasive Colon Cancer Surgery Through IMmunomics and Optical Mapping of the Sentinel Lymph Node.
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Kom Op Tegen Kanker
Conditions:
Colon Cancer
Sentinel Lymph Node
Eligibility:
All Genders
18+ years
Phase:
NA
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 im...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03779009
Start Date
March 1 2018
End Date
December 31 2025
Last Update
September 19 2024
Active Locations (1)
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1
Ghent University Hospital
Ghent, Belgium, 9000