Uterine Neoplasms Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Canada | Juravinski Hospital, Juravinski Cancer Centre, McMaster University | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Hamilton Health Sciences Corporation | Juravinski Cancer Centre Foundation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Measurement for each participant will be performed between 2-4 hours after injecting Technetium 99 in the cervix | No |
Secondary | 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) | Measurement will be performed 2-4 hours after the cervical injection with Technetium 99 | No |
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