Study to observe where we will find Indocyanine Green (ICG) in the cancerous tissues from patients with peritoneal carcinomatosis from colorectal cancer, after intravenous injection of ICG.

Phase 1

• Conditions: Imaging of tumours and their metastasis after intravenous injection ofIndocyanine Green to patients with peritoneal carcinomatosis from colorectal cancer.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-003512-37-BE
• Lead Sponsor: Jules Bordet Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-17
• Last Update Posted: 16 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified