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

Evaluation of Sentinel Lymph Node Biopsy Using Patent Blue Dye in Early-Stage Ovarian Cancer: A Prospective Observational Study

This study will try injecting Patent Blue dye into the ovarian ligaments during surgery for people with early-stage ovarian cancer to find the first draining lymph nodes and see if that can stage disease accurately while avoiding full lymph node removal.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Faculty of Medicine of Tunis (other)
• Locations: 1 site (La Rabta)
• Trial ID: NCT07508306 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with suspected early-stage (FIGO I–II) ovarian cancer on imaging who are scheduled for complete surgical staging, have no suspicious lymph nodes on preoperative scans, and have no allergy to Patent Blue dye.

Not a fit: Patients with imaging or intraoperative evidence of nodal metastasis or extra‑pelvic disease, prior pelvic lymphadenectomy or radiotherapy, or known allergy to blue dye are unlikely to benefit from this SLN mapping approach.

Why it matters

Potential benefit: If accurate, this approach could allow many patients with early ovarian cancer to avoid extensive lymphadenectomy and its complications while preserving accurate staging information.

How similar studies have performed: Sentinel lymph node mapping with dyes and tracers is well established in breast, cervical, and endometrial cancers, but evidence in early ovarian cancer is limited to small series and pilot studies rather than large confirmatory trials.

Eligibility criteria

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 this trial is running

La Rabta

• Maternity and neonatology center of Tunis — La Rabta, Tunisia (RECRUITING)

Study contacts

• Study coordinator: Mohammed Amine Hannachi, Assistant professor

Conditions: Sentinel Lymph Node Biopsy, Early Stage Ovarian Tumors, early stage ovarian cancer, sentinel lymph node, sentinel lymph node biopsy, Patent blue dye