Sentinel Lymph Node Biopsy to Assess Axillary Lymph Nodes in Women With Stage I or Stage II Breast Cancer
NCT ID: NCT00005821
Last Updated: 2013-11-06
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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UNKNOWN
PHASE2
INTERVENTIONAL
1998-12-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of sentinel lymph node biopsy to assess axillary lymph nodes in women who have stage I or stage II breast cancer.
Detailed Description
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* Compare sentinel node biopsy vs axillary dissection in determining axillary nodal status in women with resectable stage I or II breast cancer.
OUTLINE: Patients are stratified according to node status (positive vs negative).
Patients undergo lymphoscintigraphy, which consists of technetium Tc 99m human serum albumin colloid being injected near the tumor. Dynamic imaging using a gamma camera is performed for 20 minutes postinjection and static images are obtained for up to 3 hours postinjection.
Surgery is performed within 24 hours of lymphoscintigraphy. Patients are injected with patent blue V dye near the tumor and a gamma detection probe is used to measure radioactive counts in the sentinel node. Surgery begins within 5 minutes of the patent blue V dye injection.
All lymph nodes that stain blue or have a high radioactive count are removed. The primary breast lump is removed by either wide local excision or mastectomy and the axilla are cleared by standard axillary dissection.
Some patients may only receive patent blue V dye injected as a pilot study. Sentinel lymph node biopsy and axillary dissection proceed as above.
PROJECTED ACCRUAL: A total of 150 patients (75 per stratum) will be accrued for the main study plus another 50 patients for the pilot study.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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patent blue V dye
conventional surgery
lymphangiography
radionuclide imaging
sentinel lymph node biopsy
Technetium Tc 99m human serum albumin colloid
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of stage I or II invasive breast cancer by triple assessment:
* Clinically
* Mammogram and/or ultrasound
* Fine needle cytology
* Resectable disease by either wide local excision or mastectomy with axillary dissection
* No ductal carcinoma in situ
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Not pregnant
* No known allergy to vital blue dye
* No mental illness or handicap that would preclude study entry
* No other severe illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* See Disease Characteristics
18 Years
FEMALE
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Principal Investigators
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Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng)
Role: STUDY_CHAIR
Royal Marsden NHS Foundation Trust
Locations
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St. George's Hospital
London, England, United Kingdom
Royal Marsden NHS Trust
London, England, United Kingdom
Royal Brompton National, Heart and Lung Hospital
London, England, United Kingdom
Royal Marsden Hospital
Sutton, England, United Kingdom
Countries
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Other Identifiers
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RMNHS-1631
Identifier Type: -
Identifier Source: secondary_id
EU-20006
Identifier Type: -
Identifier Source: secondary_id
CDR0000067828
Identifier Type: -
Identifier Source: org_study_id