Sentinel Node Biopsy and Axillary Sampling in Operable Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00128362|
Recruitment Status : Terminated (After initiation of study many studies reported an equivalence of SNB and ALND which led to widespread adoption of the former as standard procedure.)
First Posted : August 9, 2005
Last Update Posted : June 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cancer of the Breast||Procedure: Radio-guided sentinel node biopsy Procedure: Axillary sampling||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||478 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial of Sentinel Node Biopsy Versus Axillary Sampling in Women With Clinically Node Negative Operable Breast Cancer|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||December 2011|
Experimental: Radio guided Sentinle node biopsy
The radiolabeled Tc-99 colloid or phytate (500 Mbq) will be injected into the primary tumor 2 hours before surgery. A localized scintiscan will then be performed to confirm the radiolabeling of the sentinel node before surgery and for documentation. Isosulphan blue dye will be injected subdermal (0.5ml) over the tumor and intraparenchymal (3-4ml) towards the axilla 10-15mins before incision.
Procedure: Radio-guided sentinel node biopsy
Procedure: Axillary sampling
- Comparison of methodologies in predicting status of axillary lymph nodes [ Time Frame: Within 30 days after surgery ]The patient enrolled on this study will be planned for surgery and outcome will be measured after avability of histo-pathological report.
- Number of lymph nodes identified by sentinel node biopsy and axillary sampling [ Time Frame: Within 30 days of surgery ]The patient enrolled on this study will be planned for surgery and outcome will be measured after avability of histo-pathological report.
- Number of times the sentinel node is found within the sampled nodes [ Time Frame: Within 30 days of surgery ]The patient enrolled on this study will be planned for surgery and outcome will be measured after avability of histo-pathological report.
- False negative rate by each method [ Time Frame: within 30 days of surgery ]
- Negative predictive value for each method [ Time Frame: within 30 days of surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128362
|Tata Memorial Hospital|
|Mumbai, Maharashtra, India, 400 012|
|Principal Investigator:||Rajendra A Badwe, M.S.||Tata Memorial Hospital|