Status:
COMPLETED
Imaging of Peritoneal Carcinomatosis From Ovarian Carcinoma Patients
Lead Sponsor:
Jules Bordet Institute
Conditions:
Ovarian Cancer
Peritoneal Carcinomatosis
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine if NIF fluorescent imaging is an effective approach to detect the gross ovarian tumoral tissues and peritoneal implants in Ovarian cancer patients.
Detailed Description
Primary objective: Evaluation of the ability of NIR imaging to image and to detect the " viable " gross tumoral mass and/or peritoneal metastatic " implants " in women operated for ovarian carcinoma ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01834469
Start Date
March 1 2013
End Date
October 1 2014
Last Update
October 15 2014
Active Locations (1)
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1
Jules Bordet Institute
Brussels, Belgium, B-1000