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.
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.
Age between 18 and 75 years old (≥18 and ≤75).
ECOG score: 0 - 1.
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.
Advanced epithelial ovarian cancer or retroperitoneal lymph node metastasis evaluated by preoperative imaging (enhanced CT and/or magnetic resonance scanning).
Previous history of resection or sampling of para-aortic and/or iliac vascular lymph nodes.
Previous history of abdominal aorta and/or iliac vascular surgery.
Previous allergy to indocyanine green or iodine.
Single group
Lymph node visualization
Procedure/SurgeryResect the developing lymph nodes and the systematic lymph nodes. Conduct postoperative follow-up and pay attention to the relevant indicators of the patient after surgery.
No visualization of lymph nodes
Procedure/SurgeryResect the systematic lymph nodes. Conduct postoperative follow-up and pay attention to the relevant indicators of the patient after surgery.
PFS
Progression-Free Survival (PFS) is defined as the time interval between the patient's diagnosis of gynecological malignancy and the first occurrence of progression of the disease or death from any cause.
OS
Overall Survival (OS) was defined as the time interval between the patient's diagnosis of gynecologic malignancy and death from any cause or the end of the last follow-up date.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
