Imaging of tumours and their metastasis after intravenous injection of Indocyanine Green to patients with peritoneal carcinomatosis from colorectal cancer.
Conditions
Interventions
Trade Name: Indocyanine Green Pulsion 25 mg
Product Name: Indocyanine Green
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Indocyanine Green
CAS Number: 3599-32-4
Current
Sponsors
Jules Bordet Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients (either newly diagnosed, or relapsing) with peritoneal carcinomatosis from colorectal carcinoma who are candidate for “open” surgery. - Informed consent form signed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Age less than18 years old. - Inability to give informed consent. - History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish. - Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland. - Documented coronary disease. - Advanced renal impairment (creatinine > 1,5mg/dl). - During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and heparin). - Pregnancy, breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Confirmation of the ability of NIR imaging using ICG to demonstrate tumors and peritoneal metastatic implants in patients operated for peritoneal carcinomatosis from colorectal origin. - Confirmation that mucinous lesions observed in 2 patients recruited in the last study (EudraCT 2013-000653-42) are not visualized fluorescent after IV injection of ICG. ;Secondary Objective: - Evaluation of the ability of NIR imaging using ICG to help the surgeon in scoring the peritoneal carcinomatosis before the beginning of the surgery, aiming to detect more undetectable lesions than under white light. - Evaluation of the fluorescence intensity observed in the normal tissues after IV injection of ICG depending on the timing between the injection and the excision of the tissue. ;Primary end point(s): - Confirmation of the ability of NIR imaging using ICG to demonstrate tumors and peritoneal metastatic implants in patients operated for peritoneal carcinomatosis from colorectal origin. - Confirmation that mucinous lesions observed in 2 patients recruited in the last study (EudraCT 2013-000653-42) are not visualized fluorescent after IV injection of ICG. ;Timepoint(s) of evaluation of this end point: After surgery and pathological analysis of the patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Evaluation of the ability of NIR imaging using ICG to help the surgeon in scoring the peritoneal carcinomatosis before the beginning of the surgery, aiming to detect more undetectable lesions than under white light. - Evaluation of the fluorescence intensity observed in the normal tissues after IV injection of ICG depending on the timing between the injection and the excision of the tissue. ;Timepoint(s) of evaluation of this end point: After surgery and pathological analysis of the patient | — |
Countries
Belgium
Contacts
Public ContactDr Gabriel Liberale
Jules Bordet Institute
Outcome results
None listed