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Analysis of Parametrial Lymph Nodes as Sentinel Nodes in Patients With Cervical Cancer

NCT00631241 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-05-02

No results posted yet for this study

Summary

The goal of this clinical research study is to find out if the parametrial nodes are "sentinel" nodes (the lymph nodes believed to be the greatest risk for the spread of cancer) and if intraoperative lymphatic mapping can identify "sentinel" lymph nodes in the parametrium (the tissue that is on either side of the cervix). Identifying these lymph nodes may help to predict the status of the remaining lymph nodes in the pelvis. This research will also determine if India Ink is safe to use with the blue dye and radioactive tracer and if it improves the process of identifying the sentinel nodes.

Conditions

Interventions

PROCEDURE

Single Photon Emission Computed Tomography

First 3 Patients = Performed 30-45 minutes, 2-3 hours, and 20-24 hours after injections of the radioactive material or just before surgery; Remaining 17 Patients = Performed only one at a time as was found to be best based on the scans from first 3 patients.

PROCEDURE

Intraoperative Lymphatic Mapping

Isosulfan Blue and India ink will be injected into the cervix to help the surgeon identify the sentinel nodes by their blue color and their level of radioactivity.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Michael M. Frumovitz, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00631241 on ClinicalTrials.gov