Selective Sentinella Lymph Node Biopsy with Indocyanine Green in Patients with Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorOmphis Foundation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Lymphadenectomy
Trial population
Any patient with breast cancer who recieve surgery and required to perform lymph node detection
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Application of green indocyanine colorant
Other interventionThe 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
DrugApplication of a periareolar injectionof TEchnetium 99 in order to detect the axillary lymph node
Treatment groups
No treatment groups listed
Trial outcomes
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
Time frame
patients included from 1 January of 2024 til January 1 2029Secondary outcomes
1
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
Time frame
patients included from 1 January of 2024 til January 1 20292
surgery time in minutes
Time in minutes from skin incision to lymp node removal.
Time frame
patients included from 1 January of 2024 til January 1 2029Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov