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The value of sentinel lymph node biopsy (SLNB) in patients underwent neoadjuvant chemotherapy is controversial. Lower detection rate and higher false negative rate are the main problem. The purpose of this study is to determine the detection rate and the false negative rate of SLNB by indocyanine green (ICG) in addition to blue dye (methylene blue) after neoadjuvant chemotherapy in patients with large or locally advanced breast cancer. This is a single arm clinical trial.
Patients indicated for neoadjuvant therapy would be recruited in this study. During the surgery, SLNB using the dual tracing method would be applied before axillary clearance. After the surgery, histological results of the SLN and non-SLN would be analysed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICG+Methylene Blue | ICG+Methylene Blue: Sentinel Lymph Node (SLN) identification and resection using dual tracer technique with the sub-areolar injection of ICG+Blue dye, before surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICG+Methylene Blue | Procedure | ICG+Methylene Blue Arm: One ml of methylene blue (1%) would be in injected sub-areolarly 5 minutes before surgery, and 1ml of ICG (0.125%) in the same site 3 minutes later. Massage of the breast would be applied to facilitate the movement of the tracers. A small incision would be made in the axilla, and a special device would be used to search the light nodes. During the sampling, blue nodes would also be resected . After the completion of SLNB, complete axillary dissection would be carried out. |
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate of SLN | The number of successful SLNB / total number of SLNB | Immediate |
| Measure | Description | Time Frame |
|---|---|---|
| False negative rate of SLNB | The number of patients with positive SLN / the number of patients with positive node | 1 week after the surgery |
| Adverse effect | Prophylaxis reaction, skin complication |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with large operable or locally advanced breast cancer underwent neoadjuvant therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Houpu Yang, M.D. | Contact | +86-10-88324010 | yanghoupu@pkuph.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shu Wang, M.D. | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Breast Center, Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23683750 | Background | Kuehn T, Bauerfeind I, Fehm T, Fleige B, Hausschild M, Helms G, Lebeau A, Liedtke C, von Minckwitz G, Nekljudova V, Schmatloch S, Schrenk P, Staebler A, Untch M. Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study. Lancet Oncol. 2013 Jun;14(7):609-18. doi: 10.1016/S1470-2045(13)70166-9. Epub 2013 May 15. | |
| 24101169 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Half a year after the surgery |
| Background |
| Boughey JC, Suman VJ, Mittendorf EA, Ahrendt GM, Wilke LG, Taback B, Leitch AM, Kuerer HM, Bowling M, Flippo-Morton TS, Byrd DR, Ollila DW, Julian TB, McLaughlin SA, McCall L, Symmans WF, Le-Petross HT, Haffty BG, Buchholz TA, Nelson H, Hunt KK; Alliance for Clinical Trials in Oncology. Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer: the ACOSOG Z1071 (Alliance) clinical trial. JAMA. 2013 Oct 9;310(14):1455-61. doi: 10.1001/jama.2013.278932. |
| 39731298 | Derived | Liu M, Yang Y, Hua B, Feng R, Xu T, Wang M, Qi X, Cao Y, Zhou B, Tong F, Liu P, Liu H, Cheng L, Yang H, Xie F, Wang S, Wang C, Peng Y, Shen D, Chen L, Jiang J, Wang S. Indocyanine Green Fluorescence Plus Blue Dye for Sentinel Lymph Node Biopsy in Patients Undergoing Neoadjuvant Chemotherapy for Breast Cancer: A Multicenter, Prospective Cohort Study. Thorac Cancer. 2025 Jan;16(2):e15511. doi: 10.1111/1759-7714.15511. Epub 2024 Dec 27. |
| D017437 |
| Skin and Connective Tissue Diseases |