Actively Recruiting
Efficacy of OneMark Device in Identifying Breast Cancer for Surgery and Surveillance
Led by University of California, San Diego · Updated on 2026-02-03
60
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
V
View Point Medical
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of OneMark Device in Identifying Breast Cancer for Surgery and Surveillance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent provided.
- Willingness to follow all study procedures and be available for the study duration.
- Age 18 years or older.
- In good general health based on medical history.
- Able to undergo general anesthesia for surgery.
- Post-menopausal for those capable of menstruating, defined as no menses for 12 months or age over 60.
- For surgery group: male or female with stage T1/T2 breast cancer visible by ultrasound.
- For surveillance group: male or female with abnormal mammogram BI-RADS category 4 or 5.
- Ultrasound-visible unifocal breast tumor less than 5 cm.
- Breast tissue density low (category A or B) or high (category C or D) by mammogram.
You will not qualify if you...
- Pregnant or breastfeeding.
- Known allergy to components of OneMark or SAVI SCOUT.
- Feverish illness within 7 days before device placement.
- Treatment with investigational drug or intervention within 1 month before enrollment.
- Neoadjuvant chemotherapy within 6 months before enrollment.
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Trial Site Locations
Total: 1 location
1
University of California, San Diego
La Jolla, California, United States, 92093
Actively Recruiting
Research Team
S
Sara M Grossi, MD
CONTACT
B
Breast Research Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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