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Diagnostic Study of Patent Blue V Dye to Identify Sentinel Lymph Nodes in Patients With Stage I or IIA Breast Cancer (NCT00003654)

RATIONALE: Diagnostic procedures, such as blue dye or imaging to identify sentinel lymph nodes, may improve the ability to detect the extent of disease and help plan effective surgery for removing breast tumors. PURPOSE: Diagnostic trial to study the effectiveness of blue dye and an imaging procedure to identify the sentinel lymph node under the arm in women with stage I or stage II breast cancer.
  • Drug: patent blue V dye
    • Procedure: lymphangiography
      • Procedure: radionuclide imaging
        • Procedure: sentinel lymph node biopsy
          • Radiation: technetium Tc 99m sulfur colloid
            Ages eligible for Study
            all
            Genders eligible for Study
            Female
            Accepts Healthy Volunteers
            No
            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.

            1 locations

            France (1)
            • Centre Paul Strauss
              Not specified
              Strasbourg, France, 67085
            Status:
            unknown
            Type:
            Interventional
            Phase:
            -
            Start:
            31 August, 1997
            Updated:
            05 February, 2009
            Participants:
            200
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