EUCTR2013-000276-15-BE
Active, not recruiting
Phase 1
Feasibility study of the (intravenously injected) Indocyanine green (ICG) imaging of tumoral implants in patients with peritoneal carcinomatosis from ovarian carcinoma
DrugsICG Pulsion
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Jules Bordet Institute
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Patients (either newly diagnosed, or relapsing) with histo\-pathological diagnosis of ovarian carcinoma and peritoneal carcinomatosis who are candidate for open” surgery, either after neo\-adjuvant chemotherapy (80\-90% of the cases), or in first intent”.
- •\- 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 dissemi\-nated autonomies of the thyroid gland.
- •\- Documented coronary disease.
- •\- Advanced renal impairment (creatinine \> 1,5mg/dl).
Outcomes
Primary Outcomes
Not specified
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