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

NCT07593339 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-18

No results posted yet for this study

Summary

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.

Conditions

  • Epithelial Ovarian Cancer

Interventions

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.

Sponsors & Collaborators

  • Başakşehir Çam & Sakura City Hospital

    lead OTHER_GOV

Principal Investigators

  • Suleyman Tunc, MD · Basaksehir Camm and Sakura City Hospital

  • Ilkbal Temel Yuksel, MD · Basaksehir Camm and Sakura City Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-12-31
Completion
2028-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07593339 on ClinicalTrials.gov