NCT07508306Recruiting
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
Evaluation of Sentinel Lymph Node Biopsy Using Patent Blue Dye in Early-Stage Ovarian Cancer: A Prospective Observational Study
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 22 Mar 2026
- Start date
- 15 Apr 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Faculty of Medicine of Tunis
- Diseases
- Ovarian cancer
- NCT number
- NCT07508306
What you commit to
- Study type: Observational
- Planned participants: 30
- From 15 Apr 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of radiotherapy: Patients who have previously undergone pelvic or abdominal radiotherapy.
Other illness
- 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.
- Allergies: Known allergy or adverse reaction to patent blue dyes.
Other
- Suspicious nodal involvement: Presence of suspicious lymph nodes on preoperative imaging (generally defined by a short-axis diameter ≥ 10 mm).
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maternity and neonatology center of Tunis Coordinator of this site? Confirm its status | La Rabta | Tunisia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.