Sentinel Node Biopsy in Endometrial Cancer

NCT01564264UNKNOWNNAINTERVENTIONAL

Summary

The purpose of this study is to determine if there is a difference between the lymphatic drainage of the cervix and corpus of the uterus after injecting a radiocolloid in the cervix and blue dye in the corpus of the uterus and to investigate the identification rate of sentinel nodes using this technique in patients with cancer of the uterus.

Key Facts

Lead Sponsor

Hamilton Health Sciences Corporation

Enrollment

50

Start Date

2012-11-01

Completion Date

2014-12-01

Study Type

INTERVENTIONAL

Official Title

Prospective Cohort Study Evaluating Identification Rate of Sentinel Node in the Management of Endometrial Cancer Utilizing a Combined Method of Cervical and Myometrial Injections

Interventions

Sentinel Lymph Node Biopsy

Conditions

Uterine NeoplasmsSentinel Lymph Node Biopsy

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

1. Women older than 18 years old
2. Endometrial cancer
3. Histologies: Grade 2 and 3 endometrioid adenocarcinoma, clear cell and papillary serous carcinoma
4. Suitable candidates for surgery
5. Clinically stage 1 or confined to the uterus

Exclusion Criteria:

1. Grade 1 endometrioid adenocarcinoma
2. Metastatic disease

Outcome Measures

Primary Outcomes

Location of Sentinel node

Locations: internal iliac, external iliac, common iliac, paraaortic or presacral areas Location will be registered by type of sentinel nodes: blue nodes, reflecting the uterine pattern of lymphatic flow (after myometrial injection of blue dye)and hot nodes, reflecting cervical pattern of lymphatic flow (after injection of Technetium 99 in the cervix)

Time frame: Measurement for each participant will be performed between 2-4 hours after injecting Technetium 99 in the cervix

Secondary Outcomes

Identification of metastatic lymph nodes by the sentinel node procedure

Every participant will have a sentinel node procedure followed by a complete removal of the lymph nodes (gold standard), during the same surgery. Accuracy parameters of the sentinel node technique will be compared to the gold standard (complete lymphadenectomy)

Time frame: Measurement will be performed 2-4 hours after the cervical injection with Technetium 99

Locations

Juravinski Hospital, Juravinski Cancer Centre, McMaster University, Hamilton, Canada

Sentinel Node Biopsy in Endometrial Cancer