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Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Time of surgery and data analysis

Safety Issue:

No

Principal Investigator

V. Suzanne Klimberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas

Authority:

United States: Institutional Review Board

Study ID:

UAMS 04959

NCT ID:

NCT00575744

Start Date:

December 1998

Completion Date:

December 2014

Related Keywords:

  • Breast Cancer
  • Sentinel Lymph Node Biopsy
  • Axillary Node Dissection
  • Intraoperative Injection
  • Lumpectomy
  • Mastectomy
  • Breast Neoplasms

Name

Location
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205