Selective Sentinella Lymph Node Biopsy With Indocyanine Green in Patients With Breast.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Omphis Foundation
- Enrollment
- 15000
- Locations
- 1
- Primary Endpoint
- Number of Sentinel lymph node detected. Scale of numbers
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Detailed 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.
Investigators
Sandra Lopez Gordo
Doctor and head of the department of breast cancer unit Sandra Lopez Gordo
Omphis Foundation
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Sentinel lymph node detected. Scale of numbers
Time Frame: patients included from 1 January of 2024 til January 1 2029
Number of lymph node detected with Indocyanine green and number of lymph node detected iwth techetium 99. Scale of numbers
Secondary Outcomes
- 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)