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

NCT07087691 | Recruiting DMC FDA Device

• 1 other identifier: 812244
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

breast cancer; suspicion of breast cancer; fiducial; visualization device

Outcome Measures

Primary Outcomes (1)

• Comparison of visibility rankings of OneMark marker and SAVI SCOUT

  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.

  At time of surgery

Study Arms (2)

Breast cancer surgical resection

EXPERIMENTAL

Participants with stage T1/T2 breast cancer visible by ultrasound and scheduled for breast cancer surgical resection.

Device: OneMark device

Breast cancer surveillance

EXPERIMENTAL

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.

Device: OneMark device

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.

Breast cancer surgical resection; Breast cancer surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• View Point Medical: collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sara M Grossi, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara M Grossi, MD

CONTACT

(858) 822-5354; cancerCTO@health.ucsd.edu

Breast Research Team

CONTACT

(858) 822-5354; cancerCTO@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Surgery

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 28, 2025
• Study Start: December 22, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)