Using Patent Blue to map sentinel lymph nodes in early ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational diagnostic study enrolls adults with suspected FIGO stage I–II ovarian cancer who are planned for complete surgical staging. Surgeons inject Patent Blue dye into the infundibulopelvic and utero-ovarian ligaments before adnexectomy, wait 15 minutes, then explore the pelvic and para-aortic retroperitoneum to visually identify and remove stained sentinel lymph nodes. After sentinel node removal, a complete bilateral pelvic and para‑aortic lymphadenectomy is performed and all specimens undergo histopathology to compare sentinel-node findings with standard lymphadenectomy. The study records feasibility, diagnostic accuracy, and procedural safety/morbidity associated with blue-dye SLN mapping.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age : aged 18 years-old or older
* Diagnosis: Suspected Ovarian cancer on MRI finding (O-RADs 4 or 5)
* FIGO stage: Stage I or II ( Based on MRI and scanner finding)
* Planned Procedure: Patients with planned for surgical complete stadification including pelvic and para-aortic lymphadenectomy
* Consent: Signing of the written informed consent after full information has been provided

Exclusion Criteria:

* Suspicious nodal involvement: Presence of suspicious lymph nodes on preoperative imaging (generally defined by a short-axis diameter ≥ 10 mm).
* Disease extension: Radiological or intraoperative evidence of extra-pelvic metastases or peritoneal carcinomatosis.
* Surgical history: History of lymphadenectomy, lymph node sampling, or major vascular surgery involving the aorta or the iliac vessels.
* History of radiotherapy: Patients who have previously undergone pelvic or abdominal radiotherapy.
* Allergies: Known allergy or adverse reaction to patent blue dyes.

Where it's running

• Maternity and neonatology center of Tunis
  La Rabta, Tunisia Recruiting

Study contacts

• Study coordinator: Mohammed Amine Hannachi, Assistant professor
• Email: medaminehannachi3@gmail.com
• Phone: +21699696332

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.