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

18 Years
Open (Enrolling)
Uterine Neoplasms, Sentinel Lymph Node Biopsy

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Trial Information

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

About 20 percent of women diagnosed with uterine cancer have spread outside of the uterus,
mainly to the lymph nodes. If these metastases are recognized these women can still be cured
with chemotherapy and radiation. Unfortunately different kind of imaging are not very
sensitive in identifying patients with lymph node metastases and currently a complete
removal of the lymph nodes in the pelvis and around the aorta is the gold standard
diagnostic test. Sentinel node biopsy (SLNB) is a surgical technique that aims to identify
the nodes that drain specifically the area were the tumor is located. A tracer is injected
around the tumor and then the locoregional lymph nodes are tested for the presence of this
tracer (blue dye and a radioactive substance). If the sentinel lymph node does not contain
cancer, then there is a high likelihood that the cancer has not spread to any other area of
the body.The benefits of doing sentinel node biopsy is that it decreases the potential
complications associated with the removal of all the lymph nodes. This technique is the
standard treatment for other cancers as breast cancer and melanoma and is emerging as a
promising technique in gynecological cancers.

There is no agreement regarding the best technique to do SLNB in women with uterine cancer
and this procedure is still at the stage of determining feasibility. Since 1996, there have
been publications aiming to determine the most appropriate way to do sentinel node in
uterine cancer. As the uterus cannot be reached preoperatively for tracer injection, the
standard approach for other tumor sites of preoperative peritumoral injection of Technetium
99 followed by intraoperative injection of blue dye has needed to be modified. Blue dye with
or without a radiocolloid have been administered either subserously (the uterus outer
layer), cervically, dually, and hysteroscopically with a wide range of results in terms of
identification rates of sentinel nodes. Certain factors as site of injection, volume and
number of injections, interval time since injection to identification of sentinel nodes and
surgical approach as laparotomy versus laparoscopy have been associated with the likelihood
of identifying these nodes.

This study plans to determine the pattern of lymphatic drainage for the cervix and corpus of
the uterus by injecting a different tracer in these 2 sites and also to incorporate all
factors that have been proved to be associated with a better identification rate of sentinel
nodes in a protocol in order to determine if this technique is feasible and reliable.

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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Location of Sentinel node

Outcome Description:

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)

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Waldo G Jimenez, MD MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

McMaster University


Canada: Hamilton Health Sciences

Study ID:




Start Date:

November 2012

Completion Date:

December 2014

Related Keywords:

  • Uterine Neoplasms
  • Sentinel Lymph Node Biopsy
  • Uterine Neoplasms
  • Sentinel Lymph Node Biopsy
  • Neoplasms
  • Endometrial Neoplasms
  • Uterine Neoplasms
  • Adenoma