NIPH Clinical Trials Search

Sentinel Lymph Node Biopsy in Ovarian Cancer

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Ovarian cancer (including fallopian tube cancer)
Date of first enrollment	27/02/2026
Target sample size	30
Countries of recruitment
Study type	Interventional
Intervention(s)	After creating the necessary surgical field for laparoscopic surgery, ICG is injected locally around the tumor. The ICG used is a solution of 25 mg of Diagnogreen dissolved in 20 mL of sterile distilled water to a concentration of 1.25 mg/mL. The total dose administered is 1.0 mL per side (0.5 mL each to the base of the ovarian ligament and the base of the ovarian suspensory ligament), for a total of 2.0 mL on both sides. Subsequently, near-infrared light is irradiated using a laparoscopic ICG system, and the sentinel lymph nodes are identified using the fluorescence emitted by ICG.

Outcome(s)

Primary Outcome	Sentinel lymph node detection rate
Secondary Outcome	(1) False negative rate (2) Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) (3) Number of sentinel lymph nodes excised (4) Detection rate of micrometastasis and isolated tumor cells in sentinel lymph node pathology (5) Incidence of adverse events relevant to this study

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Female
Include criteria	(1) Women aged 18 years or older at the time of informed consent (2) Patient diagnosed with early stage ovarian cancer who are scheduled to undergo laparoscopic radical ovarian cancer surgery requiring lymph node dissection as part of routine clinical care (3) Patient for whom written consent to participate in this study can be obtained from the patient herself after disclosure of their diagnosis
Exclude criteria	(1) Patient with a history of hypersensitivity to any component of the ICG preparation (2) Patient with a history of iodine hypersensitivity (3) Patient currently participating in another interventional study (4) Patient deemed unsuitable as study subjects by the investigator for other reasons