Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified Health Condition 2: C549- Malignant neoplasm of corpus uteri, unspecified Health Condition 3: C579- Malignant neoplasm of female genital organ, unspecified Health Condition 4: C569- Malignant neoplasm of unspecifiedovary Health Condition 5: C519- Malignant neoplasm of vulva, unspecified Health Condition 6: O- Medical and Surgical
Conditions
Interventions
Intervention1: Sentinel node detection: ICG will be injected during surgery. For cancers of endometrium and cervix: Four milliliters of 1.25 mg/ml ICG solution will be injected into the cervix divided
Sponsors
Indian Council of Medical Research, New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Biopsy proven in cases of endometrial, cervical & vulvar cancers 2. Uterine confined malignancy with no evidence of metastasis on imaging and no apparent extrauterine disease at exploration 3. Stage 1 cervical cancer with tumor size less than 4 cm 4. Patients of carcinoma vulva with negative clinical groin examination and/or imaging and a primary unifocal vulvar tumor of less than 4 cm 5. Patients with stage I and II epithelial ovarian cancers 6. Patients with suspicious ovarian masses planned for hysterectomy and or salpingo-oophorectomy
Exclusion criteria
Exclusion criteria: 1. Signs of malignant spread to the abdominal cavity on preoperative imaging 2. Patients with allergies to ICG 3. Prior history of surgery for the genital malignancy 4. Previous lymphadenectomy or lymph node sampling in the pelvic or para-aortic region 5. Suspicious lymph nodal involvement on imaging 6. Women who have received chemotherapy and/or radiation 7. Recurrent malignancy 8. Pregnant or lactating patistudy 9. Not willing to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sentinel lymph node detection rate, False negative rate and accuracy of sentinel node biopsyTimepoint: Baseline after the surgery and availability of histopathology report | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events related to sentinel lymph node procedure (CTCAE version 5.0)Timepoint: 30 months;Bilateral mapping rateTimepoint: 30 months;Mean number of sentinel nodes excisedTimepoint: 30 months;Number of patients with macro-metastases, micro-metastases and isolated tumor cells detected on ultrastagingTimepoint: 30 months;Sentinel node locationTimepoint: 30 months | — |
Countries
India
Contacts
Public ContactShalini Rajaram
AIIMS Rishikesh
Outcome results
None listed