NCT07087691

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, open-label, single-site study to evaluate the OneMark visualization device in 2 patient populations: patients with breast cancer undergoing resection surgery, and patient at high risk of breast cancer in a surveillance program. In addition, the study enrolls 2 physician populations: surgeons and radiologists specialized in breast cancer. In the surgery cohort, the investigators will compare the OneMark device to the standard of care wireless localization system, SAVI SCOUT. The visibility of the two devices will be evaluated before, during, and after surgery (ex vivo). In the surveillance cohort, the investigators will evaluate the detectability over time of the OneMark device placed as fiducial during breast biopsy in patients with low or high density breast tissue. If participants in the surveillance group will require surgery during the study, the surgeons can opt to place a SAVI SCOUT marker and will evaluate the visibility of both devices like in the cohort described above. We hypothesize that the OneMark device has superior intra-operative visibility compared to the SAVI SCOUT system for detection of breast cancer for surgical resection. We also hypothesize that, when the OneMark device is used as fiducial during surveillance, it will be visible over time.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	OneMark 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.

Timeline

• Start date: 2025-12-22
• Primary completion: 2027-09-01
• Completion: 2028-09-01
• First posted: 2025-07-28
• Last updated: 2026-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study