Sentinel Node Biopsy in Endometrial Cancer

August 29, 2014 updated by: Hamilton Health Sciences Corporation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Recruiting
        • Juravinski Hospital, Juravinski Cancer Centre, McMaster University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Waldo G Jimenez, MD MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sentinel Node Biopsy
Each participant will have both measurements, the new diagnostic test (sentinel node biopsy) and the gold standard (complete lymphadenectomy)
Procedure: Sentinel Lymph Node Biopsy
Sentinel node biopsy after injections of 0.4 mci of Technetium 99 in the cervix and 4 mL of Patent Blue into the myometrium followed by standard retroperitoneal lymph node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Location of Sentinel node
Time Frame: Measurement for each participant will be performed between 2-4 hours after injecting Technetium 99 in the cervix
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of metastatic lymph nodes by the sentinel node procedure
Time Frame: Measurement will be performed 2-4 hours after the cervical injection with Technetium 99
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Juravinski Cancer Centre Foundation

Investigators

  • Principal Investigator: Waldo G Jimenez, MD MSc, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

March 23, 2012

First Submitted That Met QC Criteria

March 26, 2012

First Posted (Estimate)

March 27, 2012

Study Record Updates

Last Update Posted (Estimate)

September 3, 2014

Last Update Submitted That Met QC Criteria

August 29, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNEndometrialCa

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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