This research study investigates if SpotTM ink can help breast surgeons retrieve sampled lymph node as well as or better than the standard clip and radioseed guidance methods. The names of the novel study intervention involved in this study is: * SpotTM ink tattooing The names of the standard of care study interventions involved in this study are: * Core needle biopsy and/or fine needle aspiration * Surgical Removal of the Lymph Nodes via clip and radioseed guidance
This research study is a Feasibility Study, in which investigators are examining SpotTM ink to find out if retrieval rates of the inked lymph node at surgery are as good as or better than the standard of care, which is to clip and then radioseed-label the positive axillary lymph node. This research study involves placement of SpotTM ink on the surface of the lymph node at the time of sampling. As per standard of care, if the lymph node is positive for malignant cells, the surgeon will remove the lymph node at the time of surgical excision. The lymph node tissue will then be evaluated by the pathologist. The U.S. Food and Drug Administration (FDA) has approved SpotTM ink for use in the large intestine to mark colon polyps. The FDA has not approved SpotTM ink for use in axillary lymph nodes. However, SpotTM ink has been used in axillary lymph nodes by other institutions in smaller studies similar to this one with success in retrieving the lymph node after surgery. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will be in this research study until surgical removal of their breast cancer and lymph nodes after their tattoo ink placement.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
10
Ink injection
Brigham and Women's Hospital
Boston, Massachusetts, United States
Retrieval Rate
The primary endpoint is feasibility. Feasibility will be defined by the successful intra-operative rate of retrieval of the lymph nodes tagged by SpotTM ink versus the clip and radioseed.
Time frame: Enrollment to completion of surgery up to 1 year
Cost savings
Extrapolated by calculating cost-savings of Spot™ ink vs. clipped and radioseed-labelling lymph nodes.
Time frame: Enrollment to completion of surgery up to 1 year
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