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

NCT07593339 | Not Yet Recruiting

• 2 other identifiers: SAK-ICG-01KAEK-11/26.11.2025.448
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Sentinel Lymph Node; Indocyanine Green; Ovarian Cancer; Surgical Staging; Sentinel Lymph Node Mapping

Outcome Measures

Primary Outcomes (1)

• Detection rate of sentinel lymph nodes

  The proportion of patients in whom at least one sentinel lymph node is successfully identified using indocyanine green during surgery.

  Intraoperative period

Secondary Outcomes (4)

• Bilateral detection rate of sentinel lymph nodes

  Intraoperative period

• Number of sentinel lymph nodes identified

  Intraoperative period

• Intraoperative and postoperative complications

  Up to 30 days postoperatively

• Distribution of sentinel lymph nodes

  Intraoperative period

Study Arms (1)

Sentinel Lymph Node Mapping with ICG

EXPERIMENTAL

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; Drug: Indocyanine Green

Interventions

Sentinel Lymph Node Mapping PROCEDURE

Intraoperative sentinel lymph node mapping using indocyanine green (ICG) injected into the infundibulopelvic ligament and cervix to identify sentinel lymph nodes.

Sentinel Lymph Node Mapping with ICG

Indocyanine Green DRUG

Indocyanine green dye used for sentinel lymph node mapping.

Sentinel Lymph Node Mapping with ICG

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Ovarian Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Suleyman Tunc, MD

  Basaksehir Camm and Sakura City Hospital

  PRINCIPAL INVESTIGATOR

• Ilkbal Temel Yuksel, MD

  Basaksehir Camm and Sakura City Hospital

  STUDY CHAIR

Central Study Contacts

Suleyman Tunc, MD

CONTACT

+902129096000; stunc4668@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Single-arm prospective study evaluating sentinel lymph node mapping using indocyanine green in early-stage epithelial ovarian cancer.

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share