Ovarian cancer (including fallopian tube cancer)
Conditions
Interventions
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 distill
Sponsors
Kodama Michiko
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sentinel lymph node detection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 | — |
Contacts
Public ContactNagase Yoshikazu
The University of Osaka Hospital
Outcome results
None listed