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OneMark Device for Breast Cancer Surgery and Surveillance

This study is testing a new device called OneMark, which helps doctors locate breast cancer. The goal is to see if OneMark works better than the standard device (SAVI SCOUT) during breast cancer surgery. It also aims to find out if OneMark can be easily seen over time in patients who are being monitored for breast cancer. The study plans to enroll 60 participants who are at least 18 years old and in good general health. You would need to be willing to follow all study procedures. The current status of the study is unclear, so it's not known if they are actively recruiting.

Study design
This is a single-site study that is open-label, meaning both you and your doctors will know which device is being used. It plans to include 60 participants.
What's involved
You would undergo breast cancer surgery or surveillance as part of your regular care. If you are having surgery, the OneMark device would be placed before your operation.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07087691

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

Recruiting
NAAges 18+Interventional
University of California, San Diego
~60 participants
Updated 2026-02-03 on ClinicalTrials.gov
What's tested:OneMark device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Comparison of visibility rankings of OneMark marker and SAVI SCOUT
Measured over At time of surgery

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Sara M Grossi, MD · PRINCIPAL_INVESTIGATOR · University of California, San Diego

Who to contact

Sara M Grossi, MD
[email protected]
(858) 822-5354
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
Male and female patients with stage T1/T2 breast cancer visible by ultrasound.
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

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.

What this trial measures

  • Comparison of visibility rankings of OneMark marker and SAVI SCOUTAt time of surgery

    Visibility rankings of OneMark marker and SAVI SCOUT on a 4-point scale. Grade 0: no visibility; Grade 1: uncertain visibility; Grade 2: some visibility; Grade 3: definite visibility.