Diagnostic Study of Patent Blue V Dye to Identify Sentinel Lymph Nodes in Patients With Stage I or IIA Breast Cancer
OBJECTIVES: I. Determine whether the concept of a sentinel lymph node within the axillary
nodal basin is valid in staging breast cancer. II. Determine the sensitivity of combined
methods of identification of sentinel lymph nodes by patent blue V dye and gamma probe
detection in these women.
OUTLINE: Patients receive patent blue V dye injection peritumorally prior to surgery.
Preoperative lymphoscintigraphy is performed using technetium Tc 99 sulfur rhenium colloid
injected around the tumor associated with intraoperative gamma probe detection. Nonpalpable
tumors receive a localized injection using stereotactic injection techniques. Patients then
undergo standard axillary (level I and II) lymph node dissection.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study within 1 year.
Interventional
Primary Purpose: Diagnostic
Jean-Francois Rodier, MD
Study Chair
Centre Paul Strauss
United States: Federal Government
CDR0000066746
NCT00003654
September 1997
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