OneMark implant to help locate breast cancer for surgery and follow-up
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
This test checks whether the OneMark implant helps surgeons and radiologists see breast cancers more clearly during surgery and during imaging follow-up in adults who have or may have breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT07087691 on ClinicalTrials.gov |
What this trial studies
This is a prospective, open-label, single-site study of the OneMark visualization device in two groups: patients undergoing breast cancer resection and patients undergoing biopsy and surveillance. In the surgery group the OneMark device will be implanted before surgery and compared directly to the SAVI SCOUT wireless localization system for visibility before, during, and after surgery, with surgeons completing a visibility questionnaire. In the surveillance group the OneMark fiducial will be placed at biopsy and radiologists will rate its detectability at 1, 3, and 6 months, with an optional 12-month check. The study enrolls both surgeon and radiologist investigators to capture real-world intraoperative and imaging visibility data at a single academic center.
Who should consider this trial
Good fit: Adults (≥18) who can consent and are either undergoing surgery for ultrasound-visible T1/T2 breast cancer or are undergoing biopsy for BI-RADS 4 or 5 lesions with a unifocal, ultrasound-visible lesion <5 cm are ideal candidates.
Not a fit: Patients with multifocal or non‑ultrasound‑visible disease, lesions larger than 5 cm, those who cannot undergo biopsy or anesthesia, pregnant patients, or those ineligible for device implantation are unlikely to benefit.
Why it matters
Potential benefit: If successful, OneMark could make tumor localization and long-term imaging follow-up easier and more reliable, potentially reducing missed targets and re-operations.
How similar studies have performed: Wireless localization systems such as SAVI SCOUT have demonstrated clinical utility for intraoperative localization, but direct data on the OneMark device are limited and this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. 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). 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 1 month of enrollment. * Previous use of neoadjuvant chemotherapy within 6 months of enrollment.
Where this trial is running
La Jolla, California
- University of California, San Diego — La Jolla, California, United States (Recruiting)
Study contacts
- Principal investigator: Sara M Grossi, MD — University of California, San Diego
- Study coordinator: Sara M Grossi, MD
- Email: cancerCTO@health.ucsd.edu
- Phone: (858) 822-5354
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.