Role of Sentinel Lymph Node Evaluation Using Indocyanine Green in the Management of Early Stage Gynecological Cancers

Phase 2

Recruiting

• Conditions: Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecifiedHealth Condition 2: C549- Malignant neoplasm of corpus uteri, unspecifiedHealth Condition 3: C579- Malignant neoplasm of female genital organ, unspecifiedHealth Condition 4: C569- Malignant neoplasm of unspecifiedovaryHealth Condition 5: C519- Malignant neoplasm of vulva, unspecifiedHealth Condition 6: O- Medical and Surgical

• Registration Number: CTRI/2023/03/051086
• Lead Sponsor: Indian Council of Medical Research, New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified