Selective Sentinella Lymph Node Biopsy With Indocyanine Green in Patients With Breast Cancer

Breast Cancer Clinical Trial

— INSEAN  

Official title:

Selective Sentinella Lymph Node Biopsy With Indocyanine Green in Patients With Breast.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06378944
• Other study ID #: 61/23
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: January 1, 2029

Study information

• Verified date: April 2024
• Source: Omphis Foundation
• Contact: Sandra Lopez gordo
• Phone: 660284047
• Email: sandra.lopezgordo[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: January 1, 2029
• Est. primary completion date: January 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• Patients >18 years of age with breast cancer who are candidates for sentinel lymph node detection will be included.

• N0 patients or patients who have undergone target axillary detection with good response

Exclusion Criteria:

• Lymphadenectomy

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Application of green indocyanine colorant
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

Drug:
• Technetium99
Application of a periareolar injectionof TEchnetium 99 in order to detect the axillary lymph node

Locations

Country	Name	City	State
Spain	Sandra Lopez Gordo	Cerdanyola Del Valles	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Omphis Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	surgery time in minutes	Time in minutes from skin incision to lymp node removal.	patients included from 1 January of 2024 til January 1 2029