Efficacy of OneMark Device in Identifying Breast Cancer for Surgery and Surveillance

The goal of this research is to study a localization device for breast cancer called OneMark. This device will be studied in breast cancer surgery and during surveillance in patients being monitored for breast cancer. The main questions the study aims to answer are: Can surgeons visualize the OneMark device during breast cancer surgery better than a standard of care visualization device? Can radiologists visualize the OneMark device over time during breast cancer surveillance in patients with low or high density breast tissue? Participants will undergo breast cancer surgery or surveillance as required for their regular care. For patients undergoing surgery, the device will be implanted ahead of surgery. For patients in surveillance, the device will be implanted during biopsy and visibility of the device will be assessed by radiologists after 1, 3, and 6 months, and optionally after 12 months. Surgeons will complete a questionnaire at every surgery on the visibility of the OneMark device and the standard of care visualization device. Radiologists will complete a questionnaire after 1, 3, 6 months (and optionally after 12 months) after implantations in the patients in the surveillance program.

NCT Number	NCT07087691
Lead Sponsor	University of California, San Diego Collaborators: View Point Medical
Conditions	Breast Cancer
Enrollment	60 participants
Start Date	2025-12-22
Primary Completion	2027-09 (estimated)
Study Completion	2028-09 (estimated)
Updated on ClinicalTrials.gov	2026-02-03