Sentinel Lymph Node Mapping in Early-Stage Epithelial Ovarian Cancer Surgery

May 12, 2026 updated by: Başakşehir Çam & Sakura City Hospital

Feasibility and Evaluation of Sentinel Lymph Node Mapping in Early-Stage Epithelial Ovarian Cancer Surgery: A Tertiary Center Prospective Cohort Study

This prospective study aims to evaluate the feasibility and diagnostic performance of sentinel lymph node (SLN) mapping using indocyanine green (ICG) in patients undergoing surgery for early-stage epithelial ovarian cancer. Ovarian cancer is the most lethal gynecologic malignancy, and although systematic pelvic and paraaortic lymphadenectomy is considered a standard component of surgical staging. Moreover, systematic lymphadenectomy is associated with increased operative time, perioperative morbidity, and long-term complications such as lymphedema, without clear evidence of therapeutic benefit.

SLN mapping has been successfully implemented in other gynecologic malignancies and may provide a less invasive alternative for lymph node assessment. In this study, patients undergoing laparotomy for adnexal masses will receive intraoperative ICG injection into the infundibulopelvic ligament on the affected side and into the cervix (at the 3 and 9 o'clock positions) following intraoperative confirmation of malignant epithelial tumor by frozen section analysis. SLN detection rates, anatomical distribution, and feasibility will be assessed. In addition, intraoperative and postoperative outcomes and potential complications related to the procedure will be evaluated.

The results of this study are expected to contribute to the current evidence regarding the role of SLN mapping in early-stage epithelial ovarian cancer and may help reduce the need for systematic lymphadenectomy and its associated morbidity.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Epithelial ovarian cancer is the most lethal gynecologic malignancy, and accurate surgical staging plays a critical role in determining prognosis and guiding adjuvant treatment. Although systematic pelvic and paraaortic lymphadenectomy is considered a standard component of staging surgery in early-stage disease, the incidence of lymph node metastasis remains relatively low, and the procedure is associated with increased operative time and morbidity, including lymphedema and surgical complications.

Sentinel lymph node (SLN) mapping has been successfully adopted in other gynecologic cancers as a less invasive alternative for lymph node assessment. However, its role in early-stage epithelial ovarian cancer remains under investigation. This study is designed as a prospective cohort study conducted at a tertiary referral center.

Patients undergoing laparotomy for unilateral or bilateral adnexal masses will be included. Following intraoperative frozen section confirmation of malignant epithelial ovarian tumor, indocyanine green (ICG) will be injected into the infundibulopelvic ligament on the affected side and into the cervix at the 3 and 9 o'clock positions. Sentinel lymph nodes will be identified and evaluated.

The primary objective of the study is to assess the feasibility and detection rate of SLN mapping. Secondary objectives include evaluation of anatomical distribution of SLNs, intraoperative findings, perioperative outcomes, and potential complications.

The findings of this study are expected to contribute to the existing literature and may support the use of SLN mapping as an alternative to systematic lymphadenectomy in selected patients with early-stage epithelial ovarian cancer.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

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

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

Description

Inclusion Criteria:

  • Female patients aged 18-90 years
  • Patients undergoing laparotomy for unilateral or bilateral adnexal mass
  • Intraoperative frozen section diagnosis of malignant epithelial ovarian tumor or at least borderline epithelial tumor
  • Patients with bilateral adnexal masses who have undergone preoperative gastrointestinal evaluation (endoscopy/colonoscopy) with exclusion of gastrointestinal malignancies
  • Patients without radiological evidence of advanced-stage ovarian cancer on preoperative imaging (PET, MRI, or CT), including absence of pleural effusion, omental cake, peritoneal carcinomatosis, malignant ascites, liver or splenic parenchymal involvement, and mesenteric involvement
  • Patients who provide written informed consent

Exclusion Criteria:

  • Patients with prior lymphadenectomy
  • Patients with radiological or intraoperative evidence of advanced-stage ovarian cancer
  • Patients planned for neoadjuvant chemotherapy without primary surgery
  • Pregnant patients
  • Patients with known allergy to indocyanine green (ICG) or iodine
  • Patients with immunodeficiency disorders
  • Patients with a history of radiotherapy
  • Patients with a history of vascular surgery affecting lymphatic drainage
  • Patients with a history of vascular surgery affecting lymphatic drainage
  • Patients with a history of non-gynecological malignancy
  • Patients younger than 18 years or older than 90 years

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sentinel Lymph Node Mapping with ICG
Patients undergoing surgery for suspected early-stage epithelial ovarian cancer will receive intraoperative sentinel lymph node mapping using indocyanine green injected into the infundibulopelvic ligament and cervix.
Procedure: Sentinel Lymph Node Mapping
Intraoperative sentinel lymph node mapping using indocyanine green (ICG) injected into the infundibulopelvic ligament and cervix to identify sentinel lymph nodes.
Drug: Indocyanine Green
Indocyanine green dye used for sentinel lymph node mapping.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate of sentinel lymph nodes
Time Frame: Intraoperative period
The proportion of patients in whom at least one sentinel lymph node is successfully identified using indocyanine green during surgery.
Intraoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bilateral detection rate of sentinel lymph nodes
Time Frame: Intraoperative period
The proportion of patients in whom sentinel lymph nodes are identified bilaterally.
Intraoperative period
Number of sentinel lymph nodes identified
Time Frame: Intraoperative period
The number of sentinel lymph nodes detected per patient during surgery.
Intraoperative period
Intraoperative and postoperative complications
Time Frame: Up to 30 days postoperatively
Evaluation of complications related to sentinel lymph node mapping and surgery.
Up to 30 days postoperatively
Distribution of sentinel lymph nodes
Time Frame: Intraoperative period
Anatomical distribution of detected sentinel lymph nodes.
Intraoperative period

Collaborators and Investigators

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

Sponsor

Başakşehir Çam & Sakura City Hospital

Investigators

  • Principal Investigator: Suleyman Tunc, MD, Basaksehir Camm and Sakura City Hospital
  • Study Chair: Ilkbal Temel Yuksel, MD, Basaksehir Camm and Sakura City Hospital

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)

June 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

May 12, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAK-ICG-01
  • KAEK-11/26.11.2025.448 (Other Identifier: Basaksehir Cam and Sakura City Hospital Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to patient confidentiality and institutional data protection policies. De-identified data may be available from the corresponding author upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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