Monocentric Prospective Pilot Study Evaluating the Value of Indocyanine Green (ICG, Indocyanine Green) During a Surgical Resection of Cancerous Lesions Peritoneal Colorectal Origin.

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2014

Interventions

  • Drug: indocyanine green
    • intravenous injection (0.25mg/kg) of the indocyanine green 24h before the surgery.

Arms, Groups and Cohorts

  • patients
    • Patients (Aged 18 to 70 inclusive) with progressive colorectal cancer in intra-abdominal surgery requiring resection +/- Chemotherapy Hyperthermic Intraperitoneal

Clinical Trial Outcome Measures

Primary Measures

  • Sensitivity (true positive) of the fluorescence ex vivo compared to histological analysis s detected by fluorescence ex vivo
    • Time Frame: At the end of the surgery
    • Sensitivity (true positive) of the fluorescence ex vivo compared to histological analysis s detected by fluorescence ex vivo

Secondary Measures

  • 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
    • Time Frame: At the end of the surgery
    • Specificity (true negative) of the in-vivo fluorescence compared to histological analysis s detected by fluorescence ex vivo PCI score with and without fluorescence
  • Specificity (true negative) of the in-vivo fluorescence compared to histological analysis s detected by fluorescence ex vivo PCI score with and without fluorescence
    • Time Frame: At de begining of the surgery
    • Specificity (true negative) of the in-vivo fluorescence compared to histological analysis s detected by fluorescence ex vivo PCI score with and without fluorescence

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Saint Etienne
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gabrielle BARABINO, MD, Principal Investigator, CHU de Saint-Etienne

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