Epithelial Ovarian CancerNCT07593339
Sentinel Lymph Node Mapping in Early-Stage Epithelial Ovarian Cancer Surgery
A study testing Sentinel Lymph Node Mapping and Indocyanine Green in people with Epithelial Ovarian Cancer, run by Başakşehir Çam & Sakura City Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- Sentinel Lymph Node Mapping and Indocyanine Green
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- Sentinel Lymph Node Mapping, Indocyanine Green
- Keywords
- Sentinel Lymph Node, Indocyanine Green, Ovarian Cancer, Surgical Staging, Sentinel Lymph Node Mapping
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel Lymph Node MappingProcedure or surgery
Intraoperative sentinel lymph node mapping using indocyanine green (ICG) injected into the infundibulopelvic ligament and cervix to identify sentinel lymph nodes.
Indocyanine GreenDrug
Indocyanine green dye used for sentinel lymph node mapping.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Sentinel Lymph Node Mapping; Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative period
Secondary outcomes (4)
Bilateral detection rate of sentinel lymph nodes
The proportion of patients in whom sentinel lymph nodes are identified bilaterally.
Measured: Intraoperative period
Number of sentinel lymph nodes identified
The number of sentinel lymph nodes detected per patient during surgery.
Measured: Intraoperative period
Intraoperative and postoperative complications
Evaluation of complications related to sentinel lymph node mapping and surgery.
Measured: Up to 30 days postoperatively
Distribution of sentinel lymph nodes
Anatomical distribution of detected sentinel lymph nodes.
Measured: Intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm prospective study evaluating sentinel lymph node mapping using indocyanine green in early-stage epithelial ovarian cancer.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Suleyman Tunc, MD, Principal investigator, Basaksehir Camm and Sakura City HospitalIlkbal Temel Yuksel, MD, Study chair, Basaksehir Camm and Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593339
- Sponsor's protocol ID
- SAK-ICG-01
- Other IDs
- KAEK-11/26.11.2025.448
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.