Clinical Trial Evaluating the Effectiveness of a Tattoo Compared to a Clip Applied to Axillary Lymph Nodes in Breast Cancer Patients Who Undergo SLNBx

This study is a single-center prospective, randomized and quasi double blinded pilot study. The study has 2 parallel arms, each arm involved around 54 patients. Targeted community is the newly diagnosed adults with non metastatic and non inflammatory breast cancer in King Hussein Cancer Center who require axillary biopsy as part of their staging work up. The study aims to improve the intra-operative identification of the preoperatively suspicious and biopsied lymph nodes and test the concordance between the pre-operative clinical suspicion and histopathological results of these node; by comparing between preoperative marking of biopsied axillary lymph nodes with two different modalities (clipping Vs tattooing) and testing its concordance with sentinel lymph node biopsy, both in upfront surgery and neoadjuvant chemotherapy settings and in a prospective, randomized and quasi double blinded design

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* Age ≥ 18 years.
* Diagnosed with breast cancer.
* Scheduled for primary breast surgery with Sentinel Lymph node biopsy (SLNBx) or Axillary Lymph node dissection (ALND).
* Scheduled to undergo pre-operative axillary lymph node biopsy.
* Willing to sign the Informed Consent

Exclusion Criteria:

* Previous axillary surgeries, SLNBx and/or AD.
* Diagnosed with inflammatory breast cancer.
* Diagnosed with distant metastases.
* Known to have any allergic reaction to any of the investigational products.
* Participating in other studies involving investigational drug(s) (Phases 1-4) within 3 months prior to this study start and/or during study participation.
* Pregnant females or those with a positive pregnancy test result at screening or baseline; breastfeeding females