Health Condition 1: C50-C50- Malignant neoplasms of breast
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) All breast cancer patients who are Node negative after NACT
Exclusion criteria
Exclusion criteria: 1) Patients with Inflammatory Breast Cancer 2) Patients with history of any radiation or prior surgery to the axillary lymphatic system 3) Patients with current or history of lymphedema of limb on the affected side 4) Patients who have allergy to tracer used
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)To calculate the Identification Rate (IR) of SLNB in ycN0 Breast cancer patients using Methylene blue-Fluorescein dye combination 2)To calculate the False Negative Rate (FNR) of SLNB in ycN0 Breast cancer patients using Methylene blue-Fluorescein dye combination Timepoint: Individual data to be collected once HPE reports of SLNB and ALND specimens available (15-20 days from date of surgery) Final outcome to be calculated at end of study (30/6/2025) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To quantify the average number of SLNs identified using Methylene blue-Fluorescein dye combination in post NACT patients of Breast CancerTimepoint: Individual data to be collected intra-operatively (on day of surgery) Final outcome to be calculated at end of study (30/6/2025) | — |
Countries
India
Contacts
Department of General Surgery, All India Institute of Medical Sciences, Patna