Minimally INvasive Colon Cancer Surgery Through IMmunomics and Optical Mapping of the Sentinel Lymph Node.
NCT ID: NCT03779009
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2018-03-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Tracer injection
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Kom Op Tegen Kanker
OTHER
University Hospital, Ghent
OTHER
Responsible Party
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Locations
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Ghent University Hospital
Ghent, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Sarah Cosyns
Role: backup
Other Identifiers
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EC/2017/1356
Identifier Type: -
Identifier Source: org_study_id
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