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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

Open (Enrolling)
Breast Cancer

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Trial Information

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven stage I or IIA invasive
breast cancer T0, T1, or T2 (no greater than 3 cm), N0 Noninflammatory Nonmetastatic No
ductal carcinoma in situ Eligible for breast-conserving surgery Hormone receptor status:
Positive or negative

PATIENT CHARACTERISTICS: Age: Any age Sex: Female Menopausal status: Pre- and
postmenopausal Performance status: Not specified Life expectancy: Not specified
Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not
pregnant No allergy or sensitivity to radiopharmaceuticals or patent blue V dye

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No
prior neoadjuvant chemotherapy Endocrine therapy: No prior endocrine therapy Radiotherapy:
No prior neoadjuvant radiotherapy Surgery: No prior breast surgical biopsy or axillary

Type of Study:


Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Jean-Francois Rodier, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Paul Strauss


United States: Federal Government

Study ID:




Start Date:

September 1997

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • Breast Neoplasms