Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00507611
Status:
COMPLETED
Last Update Posted:
2012-09-25
First Post:
2007-07-25
Brief Title:
Axillary Lymph Node Status After Completion of Preoperative Neoadjuvant Systemic Chemotherapy in Patients
Sponsor:
Stephen Povoski
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Sentinel Lymph Node Mapping and Biopsy For Predicting the Axillary Lymph Node Status After Completion of Preoperative Neoadjuvant Systemic Chemotherapy in Patients Who Had Biopsy-Proven Axillary Lymph Node Involvement at Initial Presentation
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the present proposed clinical trial will be to assess the utility of SLN mapping and biopsy for predicting the final axillary status after completion of preoperative neoadjuvant systemic chemotherapy in patients who had biopsy-proven positive axillary lymph nodes at initial presentation
Detailed Description:
Multiple retrospective reports have verified the overall utility of post-treatment sentinel lymph node SLN mapping and biopsy for assessing the final axillary lymph node status in breast cancer patients who have undergone preoperative neoadjuvant systemic chemotherapy However to date only one report in abstract form currently exists within the literature which specifically assesses the utility of post-treatment SLN mapping and biopsy after completion of preoperative neoadjuvant systemic chemotherapy in patients with biopsy-proven positive axillary lymph nodes at initial presentation
The purpose of the present proposed clinical trial will be to assess the utility of SLN mapping and biopsy for predicting the final axillary status after completion of preoperative neoadjuvant systemic chemotherapy in patients who had biopsy-proven positive axillary lymph nodes at initial presentation
All eligible patients must have biopsy-proven invasive breast cancer and must also have biopsy-proven involvement of the axillary lymph nodes at initial presentation Biopsy-proven involvement of the axillary lymph nodes at initial presentation will be based on fine needle aspiration FNA cytology coreTru-cut biopsy or pre-treatment SLN biopsy All eligible patients will have undergone preoperative neoadjuvant systemic chemotherapy
After completion of preoperative neoadjuvant systemic chemotherapy and on the day of definitive breast cancer surgery patients will be injected intradermally with approximately 400 microcuries of Tc-99m sulfur colloid Patients will undergo preoperative lymphoscintigraphy in the nuclear medicine department to access axillary and extra-axillary sites of localization Intraoperatively patients will also be injected with approximately 4 to 5 mL of 1 isosulfan blue dye by intradermal intraparenchymal or subareolar route Patients will undergo intraoperative identification and biopsy of all SLN candidates A confirmatory axillary lymph node dissection will then be performed on all patients
The SLN mapping and biopsy procedure that we are proposing to perform on these breast cancer patients with known positive axillary lymph nodes at initial presentation will be done in an identical fashion to the SLN mapping and biopsy procedure that is currently performed as a routine and acceptable standard of care on every breast cancer patient with a clinically negative axilla at presentation
The primary endpoints of this study would be address the success of identification of the SLN and the accuracy of the SLN mapping and biopsy procedure in women having undergone preoperative neoadjuvant systemic chemotherapy who had biopsy-proven involvement of their axillary lymph nodes at initial presentation We would like to show that the proportion of women with false negative SLN biopsy results is less than 10
The study will require a minimum of 49 women with newly diagnosed breast cancer with biopsy-proven involvement of their axillary lymph nodes at initial presentation that have undergone preoperative neoadjuvant systemic chemotherapy The study accrual time may take in the range of approximately 24 to 36 months to complete
The purpose of the present proposed clinical trial will be to assess the utility of SLN mapping and biopsy for predicting the final axillary status after completion of preoperative neoadjuvant systemic chemotherapy in patients who had biopsy-proven positive axillary lymph nodes at initial presentation
All eligible patients must have biopsy-proven invasive breast cancer and must also have biopsy-proven involvement of the axillary lymph nodes at initial presentation Biopsy-proven involvement of the axillary lymph nodes at initial presentation will be based on fine needle aspiration FNA cytology coreTru-cut biopsy or pre-treatment SLN biopsy All eligible patients will have undergone preoperative neoadjuvant systemic chemotherapy
After completion of preoperative neoadjuvant systemic chemotherapy and on the day of definitive breast cancer surgery patients will be injected intradermally with approximately 400 microcuries of Tc-99m sulfur colloid Patients will undergo preoperative lymphoscintigraphy in the nuclear medicine department to access axillary and extra-axillary sites of localization Intraoperatively patients will also be injected with approximately 4 to 5 mL of 1 isosulfan blue dye by intradermal intraparenchymal or subareolar route Patients will undergo intraoperative identification and biopsy of all SLN candidates A confirmatory axillary lymph node dissection will then be performed on all patients
The SLN mapping and biopsy procedure that we are proposing to perform on these breast cancer patients with known positive axillary lymph nodes at initial presentation will be done in an identical fashion to the SLN mapping and biopsy procedure that is currently performed as a routine and acceptable standard of care on every breast cancer patient with a clinically negative axilla at presentation
The primary endpoints of this study would be address the success of identification of the SLN and the accuracy of the SLN mapping and biopsy procedure in women having undergone preoperative neoadjuvant systemic chemotherapy who had biopsy-proven involvement of their axillary lymph nodes at initial presentation We would like to show that the proportion of women with false negative SLN biopsy results is less than 10
The study will require a minimum of 49 women with newly diagnosed breast cancer with biopsy-proven involvement of their axillary lymph nodes at initial presentation that have undergone preoperative neoadjuvant systemic chemotherapy The study accrual time may take in the range of approximately 24 to 36 months to complete
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None