Actively Recruiting

Age: 18Years +
FEMALE
NCT07508306

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

Led by Faculty of Medicine of Tunis · Updated on 2026-04-02

30

Participants Needed

1

Research Sites

97 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Suspected ovarian cancer on MRI with O-RADs classification 4 or 5
  • FIGO stage I or II based on MRI and CT scan
  • Planned complete surgical staging including pelvic and para-aortic lymphadenectomy
  • Signed written informed consent after receiving full information
Not Eligible

You will not qualify if you...

  • Suspicious lymph nodes on preoperative imaging defined by short-axis diameter ≥ 10 mm
  • Evidence of extra-pelvic metastases or peritoneal carcinomatosis on imaging or during surgery
  • History of lymphadenectomy, lymph node sampling, or major vascular surgery involving the aorta or iliac vessels
  • Previous pelvic or abdominal radiotherapy
  • Known allergy or adverse reaction to patent blue dyes

AI-Screening

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Trial Site Locations

Total: 1 location

1

Maternity and neonatology center of Tunis

La Rabta, Tunisia, 1007

Actively Recruiting

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Research Team

M

Mohammed Amine Hannachi, Assistant professor

CONTACT

K

Khaled Neji, Professor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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