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

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT07087691
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OneMark device — 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.

Study Details

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.

Key Dates

Start date
Dec 22, 2025
Status verified
Jan 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Breast cancer surgical resection
    Participants with stage T1/T2 breast cancer visible by ultrasound and scheduled for breast cancer surgical resection.
  • Experimental: Breast cancer surveillance
    Participants with Breast Imaging Reporting and Data System (BI-RADS) category 4 or 5 on screening mammogram, with lesions visible by ultrasound, and entered in a surveillance program.

Primary Outcome Measure

Comparison of visibility rankings of OneMark marker and SAVI SCOUT [ Time Frame: At time of surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92093
Sara M Grossi, MD
[email protected]
(858) 822-5354
Breast Research Team
[email protected]
(858) 822-5354

Find similar trials in La Jolla, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of California, San Diego· La Jolla, CA

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