Stopped: Pending biocompatibility testing
This phase I study assesses the safety, ultrasound visibility (conspicuity), and movement from normal position (migration) of the twinkling marker in patients with breast cancer that has spread to the axillary lymph nodes (locally advanced) who will be undergoing neoadjuvant systemic therapy and surgery. Biopsy markers are used to identify the sites of cancer involvement in both the breasts and lymph nodes. These biopsy markers are needed to help guide breast cancer surgery. Twinkling markers are designed to have the same size and shape of conventional biopsy markers, but are made of a radio-opaque material that assists with localization of the marker. The twinkling marker may make it more easily seen with ultrasound at the time of breast cancer surgery as compared to conventional biopsy markers.
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Long-term efficacy of the twinkling marker
Timeframe: through study completion, an average of 4 months