Clinical trial · Observational
Monocentric Prospective Pilot Study Evaluating the Value of Indocyanine Green (ICG, Indocyanine Green) During a Surgical Resection of Cancerous Lesions Peritoneal Colorectal Origin.
- 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)
Between 30% and 40% of patients with colorectal cancer develop metastatic disease intraperitoneally. The optimal treatment of this disease combines surgery and chemotherapy but requires resection of all lesions larger than 2mm. Indocyanine green has an affinity for tumor tissues and the interest of its use has been demonstrated for the detection of sentinel lymph node and some liver surgeries. The ability of indocyanine green to detect peritoneal carcinomatosis in humans has never been evaluated. This study aims to evaluate the diagnostic performance of fluorescence in the detection of malignant cells in peritoneal carcinomatosis of colorectal origin compared with pathological analysis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| indocyanine green | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- patients
- description
- Patients (Aged 18 to 70 inclusive) with progressive colorectal cancer in intra-abdominal surgery requiring resection +/- Chemotherapy Hyperthermic Intraperitoneal
- interventionNames
- Drug: indocyanine green
Primary outcomes (1)
- measure
- Sensitivity (true positive) of the fluorescence ex vivo compared to histological analysis s detected by fluorescence ex vivo
- timeFrame
- At the end of the surgery
- description
- Sensitivity (true positive) of the fluorescence ex vivo compared to histological analysis s detected by fluorescence ex vivo
Secondary outcomes (2)
- measure
- Specificity (true negative) of the in-vivo fluorescence compared to histological analysis s detected by fluorescence ex vivo peritoneal cancer index (PCI) score with and without fluorescence
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with progressive colorectal cancer in intra-abdominal surgery requiring resection + / - Chemotherapy Hyperthermic Intraperitoneal * Aged 18 to 70 inclusive * Signature information form and consent by the patient Exclusion Criteria: * Pregnant women, a urine pregnancy test or blood will be realized within 72 hours before surgery * Contraindication to surgery * Diagnosis not confirmed colorectal adenocarcinoma * Persons major subject of legal protection or unable to consent
References
Publications (0)
Data not yet available