Intra-Operative Lymphatic Mapping in Patients With Invasive Carcinoma of the Cervix or Endometrial Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- To determine the feasibility of identifying the sentinel lymph node in patients with endometrial and invasive cervical cancer using a combination of radioisotope and blue dye.
研究概览
简要总结
The purpose of this study is to learn if a surgical technique called intraoperative lymphatic mapping can accurately identify the lymph node that is at greatest risk if endometrial or cervical cancer spreads to the lymph nodes.
Early cervical cancer is usually treated by removing the cervix, tissue around the cervix, and the upper vagina. If needed, the uterus is also removed. The treatment also includes removing lymph nodes from the pelvis. Endometrial cancer is usually treated by removing the cervix, uterus, fallopian tubes and ovaries.
The treatment also includes removing lymph nodes from the pelvis.
详细描述
Patients with FIGO stage I endometrial cancer or patients with FIGO stage I-IIA invasive cervical cancer and who will be undergoing surgical management to include a lymphadenectomy.
↓ Injection of radioisotope and preoperative lymphoscintigraphy with Tc99m either the day before or on the day of surgery by the Nuclear Medicine Department.
↓ Intraoperative lymphatic mapping with blue dye and gamma probe.
↓ Hysterectomy, Radical hysterectomy and/or radical trachelectomy and pelvic lymphadenectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with endometrial cancer diagnosed on endometrial biopsy or dilatation and curettage.
- •Patients with invasive cervical cancer diagnosed on cervical biopsy or cone biopsy.
- •Patients with a performance status of 0, 1, 2, or 3 by the Gynecologic Oncology Group criteria (Appendix).
- •Patients with stage I to ~IIA invasive cervical cancer disease according to the International Federation of Gynecology and Obstetrics (FIGO) clinical staging criteria (Appendix).
- •Patients with clinical stage I endometrial cancer
- •Patients who will undergo surgery to include a hysterectomy, radical hysterectomy and/or radical trachelectomy and bilateral lymphadenectomy via laparotomy or laparoscopy
- •Patients who have signed an approved informed consent.
排除标准
- •Patients with history of prior pelvic or para-aortic lymphadenectomy.
- •Patients with stage IIB-IV invasive cervical cancer by FIGO criteria.
- •Patients with recurrent endometrial or cervical cancer.
- •Patients with prior pelvic radiation.
- •Any patient with endometrial or cervical cancer treated with neoadjuvant chemotherapy and radiation therapy.
- •Patients with a performance score of 4 by the Gynecologic Oncology Group criteria or who are not good surgical candidates (Appendix).
- •Patients with grossly infected primary tumors.
- •Patients with known allergy to triphenyl-ethane compounds.
- •Patients with known deficiency of Glucose-G-Phosphate Dehydrogenase.
- •Patients with known Hemolytic Anemia from Pyruvate Kinase and G6PD Deficiencies.
- •Severe Renal Disease.
结局指标
主要结局
To determine the feasibility of identifying the sentinel lymph node in patients with endometrial and invasive cervical cancer using a combination of radioisotope and blue dye.
时间窗: 7 years
次要结局
- To determine the feasibility of locating sentinel nodes in the pelvis and/or paraaortic region with preoperative lymphoscintigraphy.(7 years)
- To document the location of the sentinel nodes in patients with invasive cervical cancer.(7 years)