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Completed

NCT Number: NCT00575744

Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Arkansas For Medical Sciences

Little Rock, Arkansas, 72205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sentinel node biopsy

Procedure

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 outcomes

  1. To continue gathering data relating to the sentinel lymph node biopsy procedure.

    Time frame: Time of surgery and data analysis

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Important dates

Study start
1998
Primary completion
2010
Study completion
2011
First posted
Dec 18, 2007
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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