Intra-Operative Lymphatic Mapping in Patients With Invasive Carcinoma of the Cervix or Endometrial Carcinoma
|ClinicalTrials.gov Identifier: NCT00595725|
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : September 8, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Endometrial Cancer Cervical Carcinoma||Other: Lymphatic Mapping||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||151 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intra-Operative Lymphatic Mapping in Patients With Invasive Carcinoma of the Cervix or Endometrial Carcinoma|
|Study Start Date :||February 2003|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
Other: Lymphatic Mapping
Intra-Operative Lymphatic Mapping
- 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. [ Time Frame: 7 years ]
- To determine the feasibility of locating sentinel nodes in the pelvis and/or paraaortic region with preoperative lymphoscintigraphy. [ Time Frame: 7 years ]
- To document the location of the sentinel nodes in patients with invasive cervical cancer. [ Time Frame: 7 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00595725
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Mary Gemignani, MD||Memorial Sloan Kettering Cancer Center|