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Sponsored by: |
University of Arkansas |
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Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00575744 |
We continue to collect information in support of the hypothesis that the histology of the first draining lymph node (sentinel node) accurately predicts the histology of the rest of the axillary lymph nodes.
Condition | Intervention | Phase |
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Breast Cancer |
Procedure: Sentinel Node Biopsy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation |
Estimated Enrollment: | 1000 |
Study Start Date: | December 1998 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention |
Procedure: Sentinel Node Biopsy
Once the patient is asleep under anesthetic, they receive an intraoperative injection of 1.0 mCi of Technetium-99 sulfur colloid into normal breast tissue surrounding the primary cancer or biopsy cavity directed subareolar or around the tumor. This is followed by blue dye injected in the subareolar complex approximately 5 minutes prior to incision. The sentinel node biopsy is performed, followed by lumpectomy/mastectomy, and a completion axillary node dissection if the sentinel node(s) were positive.
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Using a technique combining Technetium-99 sulfur colloid and Lymphazurin Blue Dye, we have established that the sentinel node predicts the pathology results of the rest of the axillary lymph nodes. This minimally invasive technique, which can be readily performed under local anesthesia, makes the need for full axillary lymph node dissection unnecessary for most patients. If the sentinel node is negative, no further surgery is necessary. If positive, a complete axillary node dissection is performed. In addition, the injections are made while the patient is under anesthesia, reducing the physical and psychological pain that accompanies injections done pre-operatively.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Laura Adkins, MAP, CCRP | 501-296-1501 ext 11231 | lladkins@uams.edu |
Contact: Maureen Smith, RNP | 501-296-1505 ext 1115 | smithmaureena@uams.edu |
United States, Arkansas | |
University of Arkansas For Medical Sciences | Recruiting |
Little Rock, Arkansas, United States, 72205 | |
Principal Investigator: V. Suzanne Klimberg, MD |
Principal Investigator: | V. Suzanne Klimberg, MD | University of Arkansas |
Responsible Party: | University of Arkansas for Medical Sciences ( V. Suzanne Klimberg, MD ) |
Study ID Numbers: | UAMS 04959 |
Study First Received: | December 14, 2007 |
Last Updated: | July 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00575744 History of Changes |
Health Authority: | United States: Institutional Review Board |
Sentinel Lymph Node Biopsy Axillary Node Dissection Intraoperative Injection Lumpectomy Mastectomy |
Skin Diseases Anesthetics Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |