NCT00005821

Sentinel Lymph Node Biopsy to Assess Axillary Lymph Nodes in Women With Stage I or Stage II Breast Cancer

Sentinel Lymph Node Biopsy in the Assessment of Axillary Nodal Status in Operable Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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

• Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 1998-12-01
• First posted: 2003-01-27
• Last updated: 2013-11-06

Locations

4 sites across 1 country: United Kingdom