ADVANCED OVARIAN CANCER MedDRA version: 21.1 Level: PT Classification code 10070906 Term: Ovarian cancer stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10070905 Term: Ovarian cancer stage I System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: VERDE INDOCIANINA PULSION - 5MG/ML POLVERE PER SOLUZIONE INIETTABILE 5 FLACONCINI DI VETRO CONTENENTI 25 MG DI POLVERE
Product Name: VERDE INDOCIANINA
Product Code: [V04CX01]
Pharmaceutica
Sponsors
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of EOC macroscopically limited to the ovaries or the pelvis (surgical stage I-II) 2. Surgical staging 3. Age between 18 and 80 4. Performance Status (ECOG) 60 mL/min according to Cockroft formula) 5. Negative preoperative CT scan imaging for positive nodes (defined as lymph modes =65 years) yes F.1.3.1 Number of subjects for this age range 56
Exclusion criteria
Exclusion criteria: 1. FIGO stages III B, III C or IV 2. Mucinous histology 3. Previous surgery of the aorta, caval vein, and/or iliac vessels 4. Previous lymphadenectomy or lymph node sampling in the iliac or para-aortic region that could change the ovarian lymphatic drainage 5. Hepatic dysfunction defined as a Model for End-Stage Liver Disease score of 10 or greater, renal dysfunction defined as serum creatinine of 2.0 mg/dL or greater 6. Usage of any other tracer but ICG 7. History of allergy to ICG, iodine, iodine dyes, isosulfan blue, or triphenylmethane 8. History of a malignant lymphoma 9. History of a malignant tumor in the abdominal cavity 10. Concomitant other malignancies 11. Previous abdominal radiation therapy 12. Pregnancy or lactation 13. Refusal to provide written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the present study is to investigate the diagnostic accuracy of sentinel node (SLN) technique in apparent early EOC, using indocyanine green (ICG), injected in the ovarian ligaments.;Secondary Objective: Detection rate of sentinel node technique (SLN) and its safety;Primary end point(s): Specificity of the SLN analysis in predicting the positive lymphatic status at histology of apparent early stage EOC.;Timepoint(s) of evaluation of this end point: 41 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Detection rate of SLN in order to assess the feasibility of the procedure; 2. Complications rate of the procedure;Timepoint(s) of evaluation of this end point: 41 months; 41 months | — |
Countries
Italy
Contacts
Public ContactDirezione Scientifica IRCCS
Margherita Zona
Outcome results
None listed