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

March 31, 2026 updated by: Mohammed Amine HANNACHI, Faculty of Medicine of Tunis

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients, with an early-stage ovarian cancer ESOC (FIGO stage I & II), will be recruited. In our setting, the preoperative staging is based on :

  • MRI finding (O-RADs classification 4 OR 5)
  • Thoraco-abdominal CT scan
  • Gastrointestinal endoscopy (if needed)
  • Ovarian tumor biomarkers (CA 125, CA 19-9, Alpha-FP, HE4...) Or patients referred to our department for management of an ESOC with after an adnexectomy for ovarian mass.

These patients will receive a complete surgery for ovarian cancer : Peritoneal cytology, Bilateral adnexectomy, hysterectomy, pelvic lymphadenectomy, paraaortic lymphadenectomy, omentectomy and peritoneal biopsies.

Prior to the adnexectomy, surgeon will inject in subperitoneal space of the infundibular ligament (1 ml of patent blue dye: 0.5 ml in ventral and 0.5 ml in dorsal) and of the utero-ovarian ligament (1 ml of patent blue dye: 0.5 ml in ventral and 0.5 ml in dorsal). Then we will wait for 15 minutes: during which we will proceed to the adnexectomy. After 15 min, the retroperitoneal space of the pelvic and para-aortic regions was opened, and the presence of Sentinelle lymph Nodes (SLNs) was examined visually. The surgeon will record the number and location of the resected SLNs. Following the identification and removal of the SLNs, a complete systematic bilateral pelvic and para-aortic lymphadenectomy is performed. All specimen will be subject to histology analysis.

The collected data:

  1. PreOperative informations:

    • Sociodemographic data : Age, Body Mass Index, Menopausal status..
    • History: Family history of cancer, Comorbidity, surgical history..
    • Ovarian tumor biomarkers
    • PreOperative imaging: MRI, CT scan, Ultrasonography
    • Presumed FIGO stage (I or II)

  2. Peri-operative data:

    • SLN procedure: injection timing, Injected volume and site, Time to visual detection, site and number of detection
    • Operative complications: vessel injury, nerve injury and allergic reaction to dye

  3. Pathological finding:

    • tumor characterization: type (serous, mucinous,...), grade and tumor size
    • SLN analysis: SLN frozen section, SLN final ultrastaging
    • Non-SLN status after complete lymphadenectomy
    • Final FIGO stage

  4. Post-operative follow-up

    • Hospital stay duration
    • Post-operative complications (within Clavien-Dindo classification)
    • Adjuvant therapy

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient suspected with a FIGO Stage I or II ovarain cancer ( Based on MRI and scanner finding). Patients with planned for surgical complete stadification including pelvic and para-aortic lymphadenectomy.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with preoperative diagnosis of early stage ovarian cancer (FIGO stage I & II )
Patients with preoperative diagnosis (Using abdominal MRI and thoraco-abdomino-pelvic scan) of early stage ovarian cancer (FIGO stage I & II ). Paitients with O-RADs 4 or 5 MRI ovarian tumors with or without elevated ovarian tumor markers.
Procedure: Sentinel node biopsy with patent blue dye
Sentinel lymph node using patent blue dye for early ovarian cancer
Other Names:
  • sentinel lymph node biopsy using patent blue dye for early stage ovarian cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical feasibility
Time Frame: From the procedure to the pathology results at 4 weeks
Overall SLN Detection Rate: This is defined as the proportion of patients in whom at least one SLN is identified (either pelvic or para-aortic) using the blue tracer
From the procedure to the pathology results at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative predictive value
Time Frame: From the procedure till the results of pathology at 4 weeks
representing the probability that a negative SLN truly indicates that all other nodes in that drainage basin are free of disease
From the procedure till the results of pathology at 4 weeks
Sensitivity
Time Frame: From the procedure till the results of pathology at 4 weeks
The proportion of patients with node-positive disease correctly identified by the SLN technique
From the procedure till the results of pathology at 4 weeks
Anatomical Distribution
Time Frame: During the procedure
Analysis of where the SLNs are located
During the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty of Medicine of Tunis

Investigators

  • Study Chair: KHALED NEJI, Professor, Maternity and neonatology center of Tunis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

February 28, 2028

Study Registration Dates

First Submitted

March 22, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MedSchoolTunisia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The only data that i will share is specified in study description:

  • PreOperative informations:
  • Sociodemographic data : Age, Body Mass Index, Menopausal status..
  • History: Family history of cancer, Comorbidity, surgical history..
  • Ovarian tumor biomarkers
  • PreOperative imaging: MRI, CT scan, Ultrasonography
  • Presumed FIGO stage (I or II)
  • Peri-operative data:
  • SLN procedure: injection timing, Injected volume and site, Time to visual detection, site and number of detection
  • Operative complications: vessel injury, nerve injury and allergic reaction to dye
  • Pathological finding:
  • tumor characterization: type (serous, mucinous,...), grade and tumor size
  • SLN analysis: SLN frozen section, SLN final ultrastaging
  • Non-SLN status after complete lymphadenectomy
  • Final FIGO stage
  • Post-operative follow-up
  • Hospital stay duration
  • Post-operative complications (within Clavien-Dindo)
  • adjuvant therapy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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