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

Last updated: January 30, 2026
Sponsor: University of California, San Diego
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

OneMark device

Clinical Study ID

NCT07087691
812244
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Provision of signed and dated informed consent form.

  • Stated willingness to comply with all study procedures and availability for theduration 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 asno menses in the 12 months before enrollment or age > 60 years. No additionalrequirements - besides the age requirement in inclusion criterion # 3 - are neededfor 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 DataSystem (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

Exclusion Criteria:

  • 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 1month of enrollment.

  • Previous use of neoadjuvant chemotherapy within 6 months of enrollment.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: OneMark device
Phase:
Study Start date:
December 22, 2025
Estimated Completion Date:
September 30, 2028

Study 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.

Connect with a study center

  • University of California, San Diego

    La Jolla, California 92093
    United States

    Site Not Available

  • University of California, San Diego

    La Jolla 5363943, California 5332921 92093
    United States

    Active - Recruiting

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