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

NCT06378944 | Recruiting

• 1 other identifier: 61/23
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

lymph node detection; indocyanine green; breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of possitive lymph nodes

  patients included from 1 January of 2024 til January 1 2029

• surgery time in minutes

  patients included from 1 January of 2024 til January 1 2029

Interventions

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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient with breast cancer who recieve surgery and required to perform lymph node detection

You may qualify if:

• 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

You may not qualify if:

• Lymphadenectomy

Sponsors & Collaborators

• Omphis Foundation: lead

Study Sites (1)

Sandra Lopez Gordo

Cerdanyola del Vallès, Barcelona, 08290, Spain

RECRUITING

Related Publications (7)

• 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.

  PMID: 8130940 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.

  PMID: 8092905 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.

  PMID: 16541308 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.

  PMID: 16110291 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.

  PMID: 32826112 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.

  PMID: 32115177 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.

  PMID: 33156466 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Technetium-99

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sandra Lopez gordo

  46873584K

  STUDY DIRECTOR

Central Study Contacts

Sandra Lopez gordo

CONTACT

0034660284047; sandra.lopezgordo@gmail.com

Sandra Lopez gordo

CONTACT

660284047; sandra.lopezgordo@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor and head of the department of breast cancer unit Sandra Lopez Gordo

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 23, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)