Status:
COMPLETED
Analysis of Parametrial Lymph Nodes as Sentinel Nodes in Patients With Cervical Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Cervical Cancer
Eligibility:
FEMALE
Phase:
NA
Brief 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 ...
Detailed Description
Lymph nodes are glands that play an important part in your body's defense against infection. They are also the most common site of cancer spread in patients with cervical cancer. Intraoperative lympha...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00631241
Start Date
February 1 2008
End Date
September 1 2012
Last Update
May 2 2016
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030