Intra-Operative Lymphatic Mapping in Patients With Invasive Carcinoma of the Cervix or Endometrial Carcinoma

September 7, 2011 updated by: Memorial Sloan Kettering Cancer Center

The purpose of this study is to learn if a surgical technique called intraoperative lymphatic mapping can accurately identify the lymph node that is at greatest risk if endometrial or cervical cancer spreads to the lymph nodes.

Early cervical cancer is usually treated by removing the cervix, tissue around the cervix, and the upper vagina. If needed, the uterus is also removed. The treatment also includes removing lymph nodes from the pelvis. Endometrial cancer is usually treated by removing the cervix, uterus, fallopian tubes and ovaries.

The treatment also includes removing lymph nodes from the pelvis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with FIGO stage I endometrial cancer or patients with FIGO stage I-IIA invasive cervical cancer and who will be undergoing surgical management to include a lymphadenectomy.

↓ Injection of radioisotope and preoperative lymphoscintigraphy with Tc99m either the day before or on the day of surgery by the Nuclear Medicine Department.

↓ Intraoperative lymphatic mapping with blue dye and gamma probe.

↓ Hysterectomy, Radical hysterectomy and/or radical trachelectomy and pelvic lymphadenectomy.

Study Type

Interventional

Enrollment (Actual)

151

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

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with endometrial cancer diagnosed on endometrial biopsy or dilatation and curettage.
  • Patients with invasive cervical cancer diagnosed on cervical biopsy or cone biopsy.
  • Patients with a performance status of 0, 1, 2, or 3 by the Gynecologic Oncology Group criteria (Appendix).
  • Patients with stage I to ~IIA invasive cervical cancer disease according to the International Federation of Gynecology and Obstetrics (FIGO) clinical staging criteria (Appendix).
  • Patients with clinical stage I endometrial cancer
  • Patients who will undergo surgery to include a hysterectomy, radical hysterectomy and/or radical trachelectomy and bilateral lymphadenectomy via laparotomy or laparoscopy
  • Patients who have signed an approved informed consent.

Exclusion Criteria:

  • Patients with history of prior pelvic or para-aortic lymphadenectomy.
  • Patients with stage IIB-IV invasive cervical cancer by FIGO criteria.
  • Patients with recurrent endometrial or cervical cancer.
  • Patients with prior pelvic radiation.
  • Any patient with endometrial or cervical cancer treated with neoadjuvant chemotherapy and radiation therapy.
  • Patients with a performance score of 4 by the Gynecologic Oncology Group criteria or who are not good surgical candidates (Appendix).
  • Patients with grossly infected primary tumors.
  • Patients with known allergy to triphenyl-ethane compounds.
  • Patients with known deficiency of Glucose-G-Phosphate Dehydrogenase.
  • Patients with known Hemolytic Anemia from Pyruvate Kinase and G6PD Deficiencies.
  • Severe Renal 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: 1
Other: Lymphatic Mapping
Intra-Operative Lymphatic Mapping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the feasibility of identifying the sentinel lymph node in patients with endometrial and invasive cervical cancer using a combination of radioisotope and blue dye.
Time Frame: 7 years
7 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the feasibility of locating sentinel nodes in the pelvis and/or paraaortic region with preoperative lymphoscintigraphy.
Time Frame: 7 years
7 years
To document the location of the sentinel nodes in patients with invasive cervical cancer.
Time Frame: 7 years
7 years

Collaborators and Investigators

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

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Mary Gemignani, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

February 1, 2003

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

January 7, 2008

First Submitted That Met QC Criteria

January 15, 2008

First Posted (Estimate)

January 16, 2008

Study Record Updates

Last Update Posted (Estimate)

September 8, 2011

Last Update Submitted That Met QC Criteria

September 7, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-127

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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