Clinical trial · Interventional
The Application of Sentinel Lymph Node Mapping Technique in the Surgery of Early Epithelial Ovarian Cancer
A Single-Arm, Open, Multicenter, Exploratory Clinical Study on the Application of Sentinel Lymph Node Mapping Mechnique in the Surgery of Early Epithelial Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a single-arm, open, multicenter, exploratory clinical study to evaluate the feasibility, sensitivity, and specificity of sentinel lymph node (SLN) mapping technology in the population with early epithelial ovarian cancer in China. Patients with stage I-II epithelial ovarian cancer evaluated by preoperative imaging (enhanced CT and/or magnetic resonance scanning) are selected as the study population. The feasibility and value of SLN mapping technology in early epithelial ovarian cancer are explored through the location and number of sentinel lymph nodes, lymph node metastasis rate, 3-year disease-free survival rate, and the incidence of postoperative lower limb edema. The study plans to recruit 246 subjects. All subjects will receive study treatment after signing the informed consent form and passing the screening.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Sentinel Lymph Node Detection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lymph node visualization | Procedure | — | UNRESOLVED |
| No visualization of lymph nodes | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lymph node developing group
- description
- After injecting IGG intraoperatively, the developing lymph nodes and systemic lymph nodes are resected.
- interventionNames
- Procedure: Lymph node visualization
- type
- EXPERIMENTAL
- label
- lymph node non-developing group
- description
- After injecting IGG intraoperatively, the developing lymph nodes and systemic lymph nodes are resected
- interventionNames
- Procedure: No visualization of lymph nodes
Primary outcomes (1)
- measure
- PFS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Epithelial ovarian cancer evaluated as stage I-II by preoperative imaging (enhanced CT and/or magnetic resonance scanning), without retroperitoneal lymph node enlargement or with lymph node enlargement having a short diameter less than 1 cm. 2. Age between 18 and 75 years old (≥18 and ≤75). 3. ECOG score: 0 - 1. 4. Patients with appropriate bone marrow hematopoiesis function, renal function and liver function: white blood cell count \> 3.0 x 109 cells/L; platelet count \> 100 x 109/L; creatinine \< 180 μmol/L; bilirubin \< 1.5 times normal; aspartate aminotransferase/alanine aminotransferase \< 3 times normal. 5. No fertility requirement. 6. Have signed the informed consent form. Exclusion Criteria: 1. Advanced epithelial ovarian cancer or retroperitoneal lymph node metastasis evaluated by preoperative imaging (enhanced CT and/or magnetic resonance scanning). 2. Previous history of resection or sampling of para-aortic and/or iliac vascular lymph nodes. 3. Previous history of abdominal aorta and/or iliac vascular surgery. 4. Previous allergy to indocyanine green or iodine. 5. Previous history of abdominal radiotherapy. 6. Pregnant and lactating patients. 7. Those who refuse to sign the informed consent form. 8. Those who are considered by the investigator as inappropriate to participate in this trial.
References
Publications (0)
Data not yet available