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Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation

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ClinicalTrials.gov Identifier: NCT00575744
Recruitment Status : Completed
First Posted : December 18, 2007
Last Update Posted : October 27, 2016
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Procedure: Sentinel Node Biopsy Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 699 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation
Study Start Date : December 1998
Primary Completion Date : October 2010
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 1 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.
Other Names:
  • Axillary Node Dissection
  • Technitium Sulfur Colloid
  • Lymphazurin Blue Dye

Primary Outcome Measures :
  1. To continue gathering data relating to the sentinel lymph node biopsy procedure. [ Time Frame: Time of surgery and data analysis ]

Secondary Outcome Measures :
  1. To vary the techniques used in the multicenter trial and incorporate the use of blue dye along with the Technetium-99 sulfur colloid. [ Time Frame: Time of surgery and data analysis ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Breast cancer requiring lymph node evaluation
  • Clinically negative lymph nodes in the axilla
  • Willing participation following an informed consent process

Exclusion Criteria:

  • Patients with clinically positive lymph nodes
  • Pregnancy (if a pregnant female should be diagnosed with breast cancer an exception would be considered on a case to case basis)
  • Previous axillary lymphadenectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575744

United States, Arkansas
University of Arkansas For Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Principal Investigator: V. Suzanne Klimberg, MD University of Arkansas


Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00575744     History of Changes
Other Study ID Numbers: UAMS 04959
First Posted: December 18, 2007    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016

Keywords provided by University of Arkansas:
Sentinel Lymph Node Biopsy
Axillary Node Dissection
Intraoperative Injection