ovarian cancer Ovarian cancer
Conditions
Interventions
The procedure is initiated with a standard open or laparoscopic approach.
Indocyanine green (ICG) is locally injected into the utero-ovarian ligament and the infundibulopelvic ligament.
Using a near-i
D007208
Indocyanine Green
Sponsors
Amano Tsukuru
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients with stage I-IIA ovarian cancer for whom radical surgery including pelvic and para-aortic lymphadenectomy is indicated. 2. Histological subtype is not restricted. 3. Patients who, based on preoperative imaging (pelvic MRI, abdominal-pelvic CT, and/or PET/CT), show no evidence of peritoneal dissemination or distant metastasis, and no pathological lymphadenopathy (defined as short-axis diameter of 15 mm or more on CT or SUVmax of 2.5 or more on PET/CT). 4. Patients aged 18 years or older at the time of enrollment. 5. Patients with an ECOG Performance Status of 0 or 1. 6. Patients with laboratory test results within 56 days prior to enrollment that meet all of the following criteria: (1) White blood cell count of 3000/microL or more (2) Platelet count of 100000/microL or more (3) AST and ALT levels of 100 IU/L or less (4) Total bilirubin of 2.0 mg/dL or less (5) Serum creatinine of 1.5 mg/dL or less 7. Patients who have provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with a known hypersensitivity or prior adverse reaction to indocyanine green (ICG). 2. Patients with a history of iodine hypersensitivity. 3. Pregnant women, breastfeeding women, or patients who may be pregnant. 4. Patients deemed unsuitable for participation in this study at the discretion of the principal physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sentinel lymph node detection rate using indocyanine green in ovarian cancer (detection of at least one SLN). | — |
Secondary
| Measure | Time frame |
|---|---|
| Location and number of identified sentinel lymph nodes (SLNs) SLN detection rate (ipsilateral pelvic), SLN detection rate (para-aortic) Presence or absence of metastasis in each SLN Concordance rate between intraoperative frozen-section diagnosis and final permanent pathological diagnosis of SLN biopsy Incidence of adverse events (adverse reactions) | — |
Contacts
Public ContactTsukuru Amano
Shiga University of Medical Science
Outcome results
None listed