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

Completed · Not applicable

Conditions studied: Cervical Cancer

In brief

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.

Key facts

Study ID

NCT00631241

Run by

M.D. Anderson Cancer Center

People needed

20

Starts

2008-02-01

Expected to finish

2012-09-01

Last updated by the study team

2016-05-02

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients who are dispositioned to undergo radical hysterectomy or radical trachelectomy and pelvic lymphadenectomy.
• No evidence of metastases on computed tomography, magnetic resonance imaging, or PET/CT scan.
• Patients must be good surgical candidates.
• Patients who have signed an approved informed consent and authorization permitting release of personal health information.
• For patients of child-bearing age, a negative serum pregnancy test within 72 hours prior to injection of radiocolloid. Child-bearing potential is defined as not post-menopausal for 12 months or no previous surgical sterilization.

You may not qualify if…

• Patients with known allergies to triphenylmethane compounds or India ink.
• Patients with a history of retroperitoneal surgery.
• Patients with a history of pelvic irradiation.
• Patients who had a cold knife or LEEP cone biopsy within 4 weeks of enrollment.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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