RecruitingNot ApplicableNCT07087691

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

Pilot Post-Marketing Study on the Efficacy of OneMark in Identifying Breast Cancer For Surgery and Over Time in High and Low Density Breast Tissue

Sponsor

University of California, San Diego

Enrollment

60 participants

Start Date

Dec 22, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria12

Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Age ≥ 18 years.
In good general health as evidenced by medical history.
Deemed able to undergo general anesthesia for surgical resection.
For individuals who are capable of menstruating: must be post-menopausal, defined as no menses in the 12 months before enrollment or age \> 60 years. No additional requirements - besides the age requirement in inclusion criterion # 3 - are needed for individuals who are not capable of menstruating.
For surgery cohort only:
Male and female patients with stage T1/T2 breast cancer visible by ultrasound.
For surveillance cohort only:
Male and female patients with abnormal mammogram Breast Imaging Reporting and Data System (BI-RADS) category 4 or 5.
Ultrasound visible unifocal breast tumor \< 5 cm in diameter.
Low density tissue by mammogram either category A (fatty replaced) or category B (scattered densities); or high density tissue by mammogram either category C (heterogeneously dense) or category D (extremely dense).

Exclusion Criteria5

Pregnancy or lactation.
Known allergic reactions to components of OneMark System or SAVI SCOUT.
Feverish illness within 7 days of placement of the device.
Previous treatment with another investigational drug or other intervention within 1 month of enrollment.
Previous use of neoadjuvant chemotherapy within 6 months of enrollment.

Interventions

DEVICEOneMark device

The OneMark device system consists of a tumor marker preloaded in a delivery system, a handheld probe, and a display console. The OneMark marker is a metal clip with microparticles embedded in gelatin forming a hydrogel pellet. The pellet is implanted with a preloaded injector percutaneously in soft tissues, such as breast or lymph nodes, to mark a biopsy site or tissue intended for surgical removal. It can be used as a fiducial implant post-biopsy for future identification or monitoring of the tissue, and as an intra-operative localization mark. The microparticles of OneMark marker can be detected by Doppler ultrasound, magnetic resonance imaging (MRI), radiography, and OneMark Detector. During surgery, the OneMark marker may be removed with the target tissue. If patients do not require surgery, the OneMark marker can be left in place.