Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-25 @ 2:31 PM
Study NCT ID:
NCT05676866
Status:
UNKNOWN
Last Update Posted:
2023-01-09
First Post:
2023-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Targeted Axillary Lymph Node Dissection in Node Positive Breast Cancer Patients Post Neo Adjuvant Therapy
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Evaluation of Targeted Axillary Lymph Nodes Dissection in Node Positive Breast Cancer Patients Post Neo Adjuvant Therapy
Status:
UNKNOWN
Status Verified Date:
2023-01
Last Known Status:
NOT_YET_RECRUITING
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:
evaluation of targeted axillary lymph node dissection in node positive breast cancer patients post neo adjuvant therapy
Detailed Description:
Targeted axillary dissection (TAD) is a novel technique in the field of surgical oncology. During TAD, patients with node-positive breast cancer who clinically responded to neoadjuvant chemotherapy undergo resection of a previously proven metastatic node together with sentinel lymph node dissection (SLND).
Compared to sentinel lymph node dissection (SLND), axillary lymph node dissection \[ALND\] is associated with increased morbidity, higher rates of lymphedema, paraesthesia, sensory loss in the arm, and impairment in shoulder function. Patients undergoing SLND have fewer infections and a better quality of life, so axillary dissection has been largely replaced by SLND in early-stage breast cancer.
Targeted axillary dissection (TAD) is an innovative surgical procedure that emerged in an attempt to further decrease the false negative results of SLND.
Breast cancer patients suitable for neoadjuvant systemic therapy \[NAST\] with node-positive disease (N1,N2) were assessed by the multi-disciplinary team and if potentially eligible for TAD, a metallic marker\[clip\] is inserted in the suspicious node prior to neoadjuvant therapy.
The procedure is performed together with SLND using a single-tracer technique. Towards the end of NAST, a progress ultrasound and mammogram are performed to assess the breast and axillary response, Clip position within node is confirmed.
A standard surgical approach for sentinel lymph node dissection \[SLND\] is used for TAD, Patent blue dye is administered intraoperatively. dissection down to the localized node is performed. node contained the clip is subsequently sent for histology. Any residual sentinel nodes or palpable abnormal nodes are excised and examined separately.
Compared to sentinel lymph node dissection (SLND), axillary lymph node dissection \[ALND\] is associated with increased morbidity, higher rates of lymphedema, paraesthesia, sensory loss in the arm, and impairment in shoulder function. Patients undergoing SLND have fewer infections and a better quality of life, so axillary dissection has been largely replaced by SLND in early-stage breast cancer.
Targeted axillary dissection (TAD) is an innovative surgical procedure that emerged in an attempt to further decrease the false negative results of SLND.
Breast cancer patients suitable for neoadjuvant systemic therapy \[NAST\] with node-positive disease (N1,N2) were assessed by the multi-disciplinary team and if potentially eligible for TAD, a metallic marker\[clip\] is inserted in the suspicious node prior to neoadjuvant therapy.
The procedure is performed together with SLND using a single-tracer technique. Towards the end of NAST, a progress ultrasound and mammogram are performed to assess the breast and axillary response, Clip position within node is confirmed.
A standard surgical approach for sentinel lymph node dissection \[SLND\] is used for TAD, Patent blue dye is administered intraoperatively. dissection down to the localized node is performed. node contained the clip is subsequently sent for histology. Any residual sentinel nodes or palpable abnormal nodes are excised and examined separately.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: