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Clinical Trials/EUCTR2014-003512-37-BE
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.

Jules Bordet Institute0 sitesStarted: September 17, 2014Last updated:
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting

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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