OneMark implant to help locate breast cancer for surgery and follow-up

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.