Status:
UNKNOWN
Mapping Sentinel Lymph Node in Initial Stages of Ovarian Cancer
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Berta Diaz-Feijoo
Aureli Torné
Conditions:
Ovarian Cancer
Sentinel Lymph Node
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Epithelial ovarian cancer (EOC) diagnosed in the initial stage (stage I-II) require complete staging surgery to histologically assess the possible existence of peritoneal or lymph node disease. Syste...
Detailed Description
The objective of this study is to know the lymphatic drainage and, if the lesion is malignant, remove the sentinel lymph nodes to know if it can predict the involvement of the remaining lymph nodes to...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of adnexal mass with high suspicion of malignancy and frozen section examination will undergo the lymphatic map with a radiotracer.
- Patients with intraoperative diagnosis of epithelial ovarian cancer will undergo the SLN exeresis with two tracers.
- Patients with a delayed diagnosis of epithelial ovarian cancer who are candidates to undergo a re-staging surgery will undergo the SLN exeresis with two tracers.
Exclusion
- Advanced ovarian cancer (FIGO III/IV)
- Patients \<18 years
- Pregnancy or lactation
- Previous vascular surgery (cava, aorta, iliac vessels), lymphadenectomy (pelvic or paraortic) or radiotherapy (pelvic or paraortic field)
- Severe adherent syndrome that prevents tracer injection
- The SLN technique will not be performed in case of benign ovarian tumor in the frozen section or borderline tumor (since in these cases there is no clinical indication of performing a lymphadenectomy)
- Non-operable patient
- Previous adverse events to the radiotracer or ICG
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT05184140
Start Date
January 1 2021
End Date
May 1 2023
Last Update
March 7 2023
Active Locations (1)
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1
Núria Agustí Garcia
Barcelona, Spain, 08014