OneMark Device for Breast Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Pregnancy, Allergic reactions, Feverish illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called OneMark, designed to help doctors better visualize breast cancer during surgery and check-ups. The trial aims to determine if this device outperforms usual methods in surgeries and ongoing monitoring for breast cancer. It includes two groups: one undergoing surgery for early-stage breast cancer and the other in a monitoring program due to abnormal mammograms. The trial targets individuals with stage T1/T2 breast cancer visible by ultrasound or those with specific mammogram results, such as BI-RADS category 4 or 5. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance breast cancer detection and treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have used another investigational drug or had neoadjuvant chemotherapy recently, you may not be eligible.

What prior data suggests that the OneMark device is safe for breast cancer surgery and surveillance?

Research on the OneMark device shows that it helps doctors detect breast cancer during surgery and monitoring. So far, no specific reports of safety issues with the OneMark device have emerged. This study is in a "Not Applicable" phase, focusing on the device's effectiveness rather than initial safety testing.

In trials like this, researchers usually check safety by monitoring for side effects or problems during device use. Common concerns for devices include how they feel when placed in the body or if they cause discomfort. However, the trial's phase suggests the device is expected to be reasonably safe for patients.

Overall, while detailed safety data isn't available yet, the trial's focus suggests that the OneMark device is thought to be well-tolerated. Discuss any concerns with a healthcare provider before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The OneMark Device is unique because it offers a new approach to breast cancer management by enhancing how doctors monitor and treat suspicious lesions and early-stage tumors. Unlike traditional methods like mammograms or biopsies, which can be invasive or less precise, the OneMark Device utilizes advanced ultrasound technology to accurately identify and track lesions that may be cancerous. This non-invasive device not only minimizes discomfort but also provides real-time data, potentially leading to earlier and more accurate interventions. Researchers are excited about the potential for this device to enhance early detection and improve surgical planning, ultimately aiming to boost outcomes for patients with breast cancer.

What evidence suggests that the OneMark device is effective for breast cancer?

Studies have shown that the OneMark device can help doctors see breast cancer more clearly. In this trial, participants will be divided into two groups: one will use the OneMark device during breast cancer surveillance, and the other during surgical resection. Research indicates that the OneMark device might make it easier to identify breast cancer spots, potentially avoiding unnecessary biopsies. For instance, many spots initially thought to be cancerous were later found to be benign after biopsy. By using OneMark, doctors aim to better determine which spots require further testing. Initial findings suggest this could lead to fewer unnecessary procedures and more accurate treatment planning. ^{1 3 6 7 8}

Who Is on the Research Team?

Sara M Grossi, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for breast cancer patients who are either scheduled for surgery or under surveillance. Participants must be eligible for the implantation of the OneMark device, which will be used to help surgeons and radiologists track cancer.

Inclusion Criteria

Provision of signed and dated informed consent form

In good general health as evidenced by medical history

I am 18 years old or older.

Exclusion Criteria

Pregnancy or lactation

Known allergic reactions to components of OneMark System or SAVI SCOUT

Previous treatment with another investigational drug or other intervention within 1 month of enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery Preparation

Participants undergoing surgery will have the OneMark device implanted ahead of surgery

1 week

1 visit (in-person)

Surgery

Participants undergo breast cancer surgery with the OneMark device, and surgeons evaluate its visibility

1 day

1 visit (in-person)

Surveillance

Participants in the surveillance program have the OneMark device implanted during biopsy, and its visibility is assessed by radiologists

6 months

3 visits (in-person) at 1, 3, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OneMark Device

Trial Overview The study tests the OneMark device's visibility during surgery and over time in surveillance compared to standard devices. Surgeons and radiologists will use questionnaires to evaluate its effectiveness after it's implanted before surgery or during biopsy.

How Is the Trial Designed?

Group I: Breast cancer surveillance Experimental Treatment 1 Intervention

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.

Group II: Breast cancer surgical resection Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

View Point Medical

Collaborator

Citations

1. withpower.com withpower.com/trial/phase-breast-cancer-8-2025-4715f

OneMark Device for Breast Cancer · Info for Participants This device will be studied in breast cancer surgery and during surveillance in patients being monitored for breast cancer.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07087691

Efficacy of OneMark Device in Identifying Breast Cancer for ... The goal of this research is to study a localization device for breast cancer called OneMark. This device will be studied in breast cancer ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5994388/

Surgical Resection of the Primary Tumor in Women With ... We evaluated patterns of surgical care and their association with overall survival among a contemporary cohort of women with stage IV breast cancer.

4. patlynk.com patlynk.com/trial/NCT01271738

Evaluating and Comparing Two Surgical Methods for ... The amount of breast tissue removed is similar. The removal of the tumor only has up to 40% chance of reoperation because the tumor is too close to the margin.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4516043/

Survival in stage I–III breast cancer patients by surgical ... The overall 5-year all-cause survival probabilities for patients treated with BCS plus radiotherapy, mastectomy, and BCS alone were 94% (95% CI 93% to 95%), 83% ...

6. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/breast-cancer

UCSD Breast Cancer Clinical Trials for 2025 — San Diego The goal of this research is to study a localization device for breast cancer called OneMark. This device will be studied in breast cancer ...

7. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/breast-cancer

Breast Cancer clinical trials at University of California Health The goal of this research is to study a localization device for breast cancer called OneMark. ... 2+ Breast Cancer at Risk of Cardiac Toxicity.

8. app.trialscreen.org app.trialscreen.org/trials/efficacy-onemark-device-identifying-breast-cancer-surgery-surveillance-trial-nct07087691

Efficacy of OneMark Device in Identifying Breast Cancer for ... A clinical study of OneMark device for breast cancer localization. A study ... Research studies have participation criteria to protect participants' safety ...