Patent Blue SLN in Early Ovarian Cancer Prospective Study (FIGO I-II) Evaluating Patent Blue SLN Mapping. Injection Into IP/UO Ligaments in Situ. Goals: Assess Feasibility and Accuracy vs Standard Lymphadenectomy to Minimize Surgical Morbidity
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
the standard of care in case of early ovarian cancer (stage I or II) is a complete surgery. This surgery includes : hysterectomy (remove of the uterus), bilateral salpingo-oophorectomy (remove of the adnexa), omentectomy (remove of the epiploon), bilateral pelvic lymphadenectomy (remove of pelvic lymph nodes) and para-aortic lymphadenectomy (remove of para-aortic lymph nodes). This procedure is diagnostic, curative and prognostic surgery. In fact, it allows us provider care giver to stratify the stage of the cancer, hence we give the appropriate adjuvant therapy. However, this surgery, especially the extended lymphadenectomy, is associated with some risks: lymphocele, vessel injury, blood loss, morbidity, long recovery period ... In order to reduce these risks, we propose a sentinel lymph node biopsy. This intervention allows us to detect first lymph node relay whether pelvic or para-aortic. In our study, we chose the patent blue dye as a tracer. This tracer is widely used in oncologic surgery (for example in breast cancer) and approved but not in ovarian cancer yet. During surgery for early stage ovarian cancer, we will inject the patent blue dye on both side of the ovarian tumor. Then, we will check for first colorful lymph node, in both pelvic and para-aortic regions. We will send these dissected lymph node to pathology for analysis. Finally, we will continue the procedure as the standard of care. Our objective is to compare the results between the sentinel lymph node and the complete lymphadenectomy and to study the technique of sentinel lymph node biopsy using the blue patent dye as tracer.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej
- •Podejrzenie raka jajnika potwierdzone badaniem MRI
- •Wczesny stadium raka (I lub II stopnia)
- •Planowany zabieg chirurgiczny z usunięciem węzłów chłonnych w miednicy i przy aorcie
- •Dobrowolna zgoda na uczestnictwo w badaniu
✗ Disqualifies
- •Węzły chłonne podejrzane o zajęcie chorobą (powiększone powyżej 10 mm)
- •Rozprzestrzenienie się nowotworu poza miednicę lub wysiew na otrzewną
- •Wcześniejsze usuwanie węzłów chłonnych lub duża operacja naczyń w okolicach aorty
- •Wcześniejsza radioterapia brzucha lub miednicy
- •Alergia na błękit patentowy
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 10, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Maternity and neonatology center of Tunis
La Rabta, Tunisia
Trial contact
Mohammed Amine Hannachi, Assistant professor
Khaled Neji, Professor
Contact information from ClinicalTrials.gov. Contact in English.
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Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/11/2026.
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