Recruiting NCT03779009
Minimally INvasive Colon Cancer Surgery Through IMmunomics and Optical Mapping of the Sentinel Lymph Node.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll).
- Who it may be relevant to
- Registry conditions: Colon Cancer, Sentinel Lymph Node. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Interventions
- Other ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll)
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 measures
- Tumor status of the sentinel lymph node (SLN) and other lymph nodes (LN's) [Time frame: up to 1 month after surgery]
Secondary outcome measures (1)
- Immunological markers [Time frame: up to 12 months after surgery]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Belgium · 1 center
- Ghent University Hospital — Ghent
Identifiers
NCT: NCT03779009 · EC/2017/1356