Sentinel Lymph Node Detection in Early Cervical Cancer

June 14, 2019 updated by: University Health Network, Toronto

The primary objective of this study is to determine the feasibility of detecting the sentinel lymph node (SLN) in patients with early invasive cervical cancer using a combined radioisotope and blue dye technique.

The investigators hypothesize that the sentinel lymph node (first node draining the tumour/cervix) for early stage cervical cancer represents the status of the regional lymph node basin (pelvic lymph nodes) and identification of a negative SLN would negate the need for complete pelvic lymphadenectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cancers of the cervix that are small and appear to be contained in the cervix (early stage) have up to 20 percent chance of having pelvic lymph nodes involved. The standard therapy is removal of the uterus and cervix (radical hysterectomy) and removal of all pelvic lymph nodes for all women with early stage cervical cancer. This procedure can be associated with significant intraoperative and postoperative complications including increased risk of damage to blood vessels and nerves in the pelvic region (leading to bladder, bowel and sexual dysfunction) as well as lymphedema (swelling, particularly in the legs) associated with significant pelvic lymph tissue removal.

The objective of this study is to find a way to accurately identify the first lymph node that drains the tumour/cervix (SLN). If this SLN is correctly identified, and it's status (positive or negative for malignancy) is representative of the entire lymph node basin, a complete node dissection could be avoided. This could benefit many women with early stage cervical cancer, as a minority actually have evidence of disease in the nodes after surgery (between 5-20%) and limited lymph node sampling could prevent the associated complications of a full pelvic lymph node dissection.

This is a prospective cohort study. The population to be studied is patients with newly diagnosed early stage cervical cancer undergoing primary surgical intervention including radical hysterectomy and bilateral pelvic lymphadenectomy. On the morning of surgery, preoperative injection of a radiolabeled colloid will be performed in the Nuclear Medicine Department followed by SPECT/CT to visualize the radiolabelled dye. Patients will then be taken to the operating room for their planned procedure. After initiation of general anesthesia, blue dye will be injected into the patient's cervix. The surgery will proceed and all lymph nodes that are "blue" and/or "hot" will be removed surgically, their anatomic location and laterality documented and sent for frozen section intraoperatively. The radical hysterectomy or radical trachelectomy and complete systematic bilateral pelvic lymphadenectomy will then be performed. The SLN status reported by the pathologist based on the frozen section will be compared to the status of the other nodes removed after complete lymphadenectomy and reported in the final pathology report (after formalin fixation and paraffin embedding). All data on these patients will be prospectively collected.

This protocol will determine the feasibility of SLN mapping in women with early stage cervical cancer. The primary outcomes will be to measure the rate of detection of SLN using the combination of radiolabelled and blue dye (unilateral and bilateral detection rates will be reported) as well as the sensitivity and specificity of this technique, based on assessing how well the intraoperative reading of SLN frozen section corresponds with the final pathology lymph node status after examining all lymph nodes removed by complete pelvic lymphadenectomy.

In addition, the investigators will assess the usefulness of preoperative SPECT/CT in identifying SLN and whether this modality accurately identifies the lymph node basin containing SLN compared to conventional lymphoscintigram.

Study Type

Interventional

Enrollment (Actual)

75

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 Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G2M9
        • Princess Margaret Hospital

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 to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women with invasive adenocarcinoma or squamous cell carcinoma of the cervix
  2. Stages 1A1 (+LVSI), 1A2 and 1B1 (< 4 cm)
  3. If CT, MRI or PET have been performed preoperatively there must be no clear evidence of metastatic disease and/or parametrial involvement.
  4. Patients who have signed an approved informed consent.
  5. Patients who will undergo surgery that includes a radical hysterectomy and/or radical trachelectomy and bilateral lymphadenectomy via laparotomy, laparoscopy or robotic-assisted.

Exclusion Criteria:

  1. Patients with known allergy to triphenylmethane compounds
  2. Pregnant patient
  3. Patients with previous retroperitoneal surgery
  4. Patients with previous history of pelvic/abdominal radiation
  5. Patients with recurrent cervical cancer
  6. Any patient treated with neoadjuvant chemotherapy and/or radiation

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sentinel lymph node mapping
Patients who consent to the study will have preoperative and intraoperative SLN mapping performed. This will include injection of a radioisotope (Technetium 99) into the cervix and imaging (SPECT/CT) at Nuclear Medicine in the morning prior to surgery in an effort to identify the lymph node basin containing the sentinel nodes. Intraoperatively, blue dye will also be injected into the cervix to aid in location of the sentinel nodes.
Procedure: Preoperative and intraoperative SLN Mapping
Patients will undergo preoperative SLN mapping, which includes an injection of a radiocolloid and lymphosinctogram and SPECT/CT. Patients will also receive an intraoperative injection of blue dye. A handheld probe will be utilized to detect radiolabelled or "hot" nodes and direct visualization will identify blue nodes which will be labelled "Sentinel Nodes" and sent to pathology for intraoperative frozen section.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity of sentinel lymph node (SLN) detection in patients with early invasive cervical cancer using a combined radioisotope and blue dye technique.
Time Frame: Three years
Three years

Secondary Outcome Measures

Outcome Measure
Time Frame
SLN status correspondence with the overall pelvic lymph node positivity (specificity) as determined by lymphadenectomy (gold standard).
Time Frame: Three years
Three years

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

Collaborators

Princess Margaret Hospital, Canada

Investigators

  • Principal Investigator: Sarah Ferguson, MD, Princess Margaret Hospital, Canada

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 (Actual)

July 1, 2010

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

June 2, 2015

First Submitted That Met QC Criteria

September 4, 2015

First Posted (Estimate)

September 7, 2015

Study Record Updates

Last Update Posted (Actual)

June 18, 2019

Last Update Submitted That Met QC Criteria

June 14, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-1003-CE

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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