Clinical trial · Interventional
Minimally INvasive Colon Cancer Surgery Through IMmunomics and Optical Mapping of the Sentinel Lymph Node.
NCT03779009CI-TRIAL-00080755MINIMALrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tracer injection
- interventionNames
- Other: ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll)
Primary outcomes (1)
- measure
- Tumor status of the sentinel lymph node (SLN) and other lymph nodes (LN's)
- timeFrame
- up to 1 month after surgery
- description
- All LN in the resection specimen will be collected, mapped, and labeled. The SLN is defined as fluorescent hotspot that appears after injection of the tracer. Standard H\&E staining will be performed on LN sections and all mapped LN (including the SLN) will be analyzed for their tumor status.
Secondary outcomes (1)
- measure
- Immunological markers
- timeFrame
- up to 12 months after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.