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Diagnostic Study to Identify Sentinel Lymph Nodes in Women With Stage I or Stage II Breast Cancer

Sponsor
UNICANCER (Other)
Overall Status
Terminated
CT.gov ID
NCT00003654
Collaborator
(none)
200
Enrollment
1
Location
28
Actual Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: patent blue V dye
  • Procedure: lymphangiography
  • Procedure: radionuclide imaging
  • Procedure: sentinel lymph node biopsy
  • Radiation: technetium Tc 99m sulfur colloid
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Primary Purpose:
Diagnostic
Official Title:
Diagnostic Study of Patent Blue V Dye to Identify Sentinel Lymph Nodes in Patients With Stage I or IIA Breast Cancer
Actual Study Start Date :
Sep 1, 1997
Actual Primary Completion Date :
Jan 1, 2000
Actual Study Completion Date :
Jan 1, 2000

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 120 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    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 surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Paul Strauss Strasbourg France 67085

    Sponsors and Collaborators

    • UNICANCER

    Investigators

    • Study Chair: Jean-Francois Rodier, MD, Centre Paul Strauss

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    UNICANCER
    ClinicalTrials.gov Identifier:
    NCT00003654
    Other Study ID Numbers:
    • CDR0000066746
    • FRE-FNCLCC-96008
    • EU-98055
    First Posted:
    Aug 26, 2004
    Last Update Posted:
    Feb 21, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by UNICANCER
    stage I breast cancer
    stage II breast cancer
    Additional relevant MeSH terms:
    Breast Neoplasms
    Technetium Tc 99m Sulfur Colloid

    Study Results

    No Results Posted as of Feb 21, 2021