EUCTR2014-003512-37-BEActive, not recruitingPhase 1
Study of the (intravenously injected) ICG (Indocyanine Green) imaging of tumoral implants in patients with peritoneal carcinomatosis from colorectal origin.
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Jules Bordet Institute
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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