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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01982227

Enrollment

Registered

2013-11-13

Start date

2013-03-31

Completion date

2014-12-31

Last updated

2015-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Metastatic

Keywords

colorectal cancer metastatic, indocyanine green

Brief summary

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.

Interventions

DRUGindocyanine green

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

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity (true positive) of the fluorescence ex vivo compared to histological analysis s detected by fluorescence ex vivo	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

Measure	Time frame	Description
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	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	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026