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| Sponsored by: |
Royal Marsden - London |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005821 |
Purpose
RATIONALE: Diagnostic procedures such as sentinel lymph node biopsy may improve the ability to detect breast cancer and determine the extent of disease.
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: patent blue V dye Procedure: conventional surgery Procedure: lymphangiography Procedure: radionuclide imaging Procedure: sentinel lymph node biopsy Radiation: technetium Tc 99m human serum albumin colloid |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Sentinel Lymph Node Biopsy in the Assessment of Axillary Nodal Status in Operable Breast Cancer |
| Study Start Date: | December 1998 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of stage I or II invasive breast cancer by triple assessment:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United Kingdom, England | |
| Royal Brompton National, Heart and Lung Hospital | |
| London, England, United Kingdom, SW3 6NP | |
| Royal Marsden Hospital | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Royal Marsden NHS Trust | |
| London, England, United Kingdom, SW3 6JJ | |
| St. George's Hospital | |
| London, England, United Kingdom, SW17 0QT | |
| Study Chair: | Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng) | Royal Marsden - London |
More Information
| Study ID Numbers: | CDR0000067828, RMNHS-1631, EU-20006 |
| Study First Received: | June 2, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005821 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I breast cancer stage II breast cancer |
|
Skin Diseases Breast Neoplasms Breast Diseases |
|
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |
