Diagnostic Study to Identify Sentinel Lymph Nodes in Women With Stage I or Stage II Breast Cancer
NCT ID: NCT00003654
Last Updated: 2021-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
200 participants
INTERVENTIONAL
1997-09-30
2000-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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DIAGNOSTIC
Interventions
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patent blue V dye
lymphangiography
radionuclide imaging
sentinel lymph node biopsy
technetium Tc 99m sulfur colloid
Eligibility Criteria
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Inclusion Criteria
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
0 Years
120 Years
FEMALE
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Jean-Francois Rodier, MD
Role: STUDY_CHAIR
Centre Paul Strauss
Locations
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Centre Paul Strauss
Strasbourg, , France
Countries
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Other Identifiers
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FRE-FNCLCC-96008
Identifier Type: -
Identifier Source: secondary_id
EU-98055
Identifier Type: -
Identifier Source: secondary_id
CDR0000066746
Identifier Type: -
Identifier Source: org_study_id
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