Breast CancerNCT07087691
Efficacy of OneMark Device in Identifying Breast Cancer for Surgery and Surveillance
A study testing OneMark device in people with Breast Cancer, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- OneMark device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2025to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego
La Jolla, California, 92093
Sara M Grossi, MD, (858) 822-5354, cancerCTO@health.ucsd.edu
Breast Research Team, (858) 822-5354, cancerCTO@health.ucsd.edu
About this study
Official title: Pilot Post-Marketing Study on the Efficacy of OneMark in Identifying Breast Cancer For Surgery and Over Time in High and Low Density Breast Tissue
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:
Read more
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.
Read the detailed 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.
- Conditions
- Breast Cancer
- Being tested
- OneMark device
- Keywords
- breast cancer, suspicion of breast cancer, fiducial, visualization device
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OneMark deviceDevice
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 group | Role | What they receive |
|---|---|---|
| Breast cancer surgical resection | Experimental | Participants with stage T1/T2 breast cancer visible by ultrasound and scheduled for breast cancer surgical resection. Receives: 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. Receives: Device: OneMark device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start22 Dec 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- View Point Medical
- Responsible party
- Principal investigator, Sara Grossi, University of California, San Diego
- Investigators
- Sara M Grossi, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087691
- Sponsor's protocol ID
- 812244
- Status last verified
- Jan 2026
- First submitted
- 8 Jul 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Post-Marketing Study on the Efficacy of OneMark in Identifying Breast Cancer For Surgery and Over Time in High and Low Density Breast Tissue
- ClinicalTrials.gov ID
- NCT07087691
- Acronym / sponsor ID
- 812244
- Conditions
- Breast Cancer
- Keywords
- breast cancer, suspicion of breast cancer, fiducial, visualization device
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- View Point Medical
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer surgical resection | Experimental | Device: OneMark deviceParticipants with stage T1/T2 breast cancer visible by ultrasound and scheduled for breast cancer surgical resection. |
| Breast cancer surveillance | Experimental | Device: OneMark deviceParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OneMark deviceThe 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. | Device | Breast cancer surgical resection, Breast cancer surveillance |
Primary outcome
Comparison of visibility rankings of OneMark marker and SAVI SCOUT
Time frame: At 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara M Grossi, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OneMark device in people with Breast Cancer, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara M Grossi, MD ((858) 822-5354, cancerCTO@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of visibility rankings of OneMark marker and SAVI SCOUT (time frame: At time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.