NCT07593339Not yet recruiting
Sentinel Lymph Node Mapping in Early-Stage Epithelial Ovarian Cancer Surgery
Feasibility and Evaluation of Sentinel Lymph Node Mapping in Early-Stage Epithelial Ovarian Cancer Surgery: A Tertiary Center Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 12 May 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Diseases
- Ovarian cancer
- NCT number
- NCT07593339
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Jun 2026 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with prior lymphadenectomy
- Patients planned for neoadjuvant chemotherapy without primary surgery
Other illness
- Patients with radiological or intraoperative evidence of advanced-stage ovarian cancer
- 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
Age
- Patients younger than 18 years or older than 90 years
Other
- Pregnant patients
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.