Selective Sentinella Lymph Node Biopsy With Indocyanine Green in Patients With Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT06378944
- Lead Sponsor
- Omphis Foundation
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15000
- 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
- Lymphadenectomy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Sentinel lymph node detected. Scale of numbers 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 Outcome Measures
Name Time Method Number of possitive lymph nodes patients included from 1 January of 2024 til January 1 2029 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
surgery time in minutes patients included from 1 January of 2024 til January 1 2029 Time in minutes from skin incision to lymp node removal.
Trial Locations
- Locations (1)
Sandra Lopez Gordo
🇪🇸Cerdanyola Del Valles, Barcelona, Spain