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The current observational study aims to perform the sentinel lymph node in breast cancer in the usual way with technetium 99 and add a second tracer, indocyanine green. The objective is to evaluate the detection rate of the lymph node with indocyanine green compared to the usual technique.
In the operating room 1 ml of indocyaninge grenn will be injectec periareolar . After 5 minutes the lymph node will be detected and extracted. The comparison between the lymph nodes detected with Technetium 99 and indocyanine green will be analysed.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Application of green indocyanine colorant | Other | The day of the surgery 1 ml of green indocyanine colorant will be applicated periareolar. After 5 minutes the lymph node will be detected and extracted | ||
| Technetium99 | Drug | Application of a periareolar injectionof TEchnetium 99 in order to detect the axillary lymph node |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Sentinel lymph node detected. Scale of numbers | Number of lymph node detected with Indocyanine green and number of lymph node detected iwth techetium 99. Scale of numbers | patients included from 1 January of 2024 til January 1 2029 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of possitive lymph nodes | assess whether there are differences in affected lymph nodes detected with indocyanine green or technetium 99 Number of possitive lymph nodes iwh indocyanine green and with technetium 99 | patients included from 1 January of 2024 til January 1 2029 |
| surgery time in minutes |
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Inclusion Criteria:
Exclusion Criteria:
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Any patient with breast cancer who recieve surgery and required to perform lymph node detection
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandra Lopez gordo | Contact | 0034660284047 | sandra.lopezgordo@gmail.com | |
| Sandra Lopez gordo | Contact | 660284047 | sandra.lopezgordo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sandra Lopez gordo | 46873584K | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandra Lopez Gordo | Recruiting | Cerdanyola del Vallès | Barcelona | 08290 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8130940 | Background | Krag DN, Weaver DL, Alex JC, Fairbank JT. Surgical resection and radiolocalization of the sentinel lymph node in breast cancer using a gamma probe. Surg Oncol. 1993 Dec;2(6):335-9; discussion 340. doi: 10.1016/0960-7404(93)90064-6. | |
| 8092905 | Background | Giuliano AE, Kirgan DM, Guenther JM, Morton DL. Lymphatic mapping and sentinel lymphadenectomy for breast cancer. Ann Surg. 1994 Sep;220(3):391-8; discussion 398-401. doi: 10.1097/00000658-199409000-00015. |
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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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| ID | Term |
|---|---|
| C000615519 | Technetium-99 |
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Time in minutes from skin incision to lymp node removal. |
| patients included from 1 January of 2024 til January 1 2029 |
| 16541308 | Background | Goyal A, Newcombe RG, Chhabra A, Mansel RE; ALMANAC Trialists Group. Factors affecting failed localisation and false-negative rates of sentinel node biopsy in breast cancer--results of the ALMANAC validation phase. Breast Cancer Res Treat. 2006 Sep;99(2):203-8. doi: 10.1007/s10549-006-9192-1. Epub 2006 Mar 16. |
| 16110291 | Background | Kitai T, Inomoto T, Miwa M, Shikayama T. Fluorescence navigation with indocyanine green for detecting sentinel lymph nodes in breast cancer. Breast Cancer. 2005;12(3):211-5. doi: 10.2325/jbcs.12.211. |
| 32826112 | Background | Jeremiasse B, van den Bosch CH, Wijnen MWHA, Terwisscha van Scheltinga CEJ, Fiocco MF, van der Steeg AFW. Systematic review and meta-analysis concerning near-infrared imaging with fluorescent agents to identify the sentinel lymph node in oncology patients. Eur J Surg Oncol. 2020 Nov;46(11):2011-2022. doi: 10.1016/j.ejso.2020.07.012. Epub 2020 Aug 3. |
| 32115177 | Background | Goonawardena J, Yong C, Law M. Use of indocyanine green fluorescence compared to radioisotope for sentinel lymph node biopsy in early-stage breast cancer: systematic review and meta-analysis. Am J Surg. 2020 Sep;220(3):665-676. doi: 10.1016/j.amjsurg.2020.02.001. Epub 2020 Feb 7. |
| 33156466 | Background | Kedrzycki MS, Leiloglou M, Ashrafian H, Jiwa N, Thiruchelvam PTR, Elson DS, Leff DR. Meta-analysis Comparing Fluorescence Imaging with Radioisotope and Blue Dye-Guided Sentinel Node Identification for Breast Cancer Surgery. Ann Surg Oncol. 2021 Jul;28(7):3738-3748. doi: 10.1245/s10434-020-09288-7. Epub 2020 Nov 6. |
| D017437 |
| Skin and Connective Tissue Diseases |