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Comparing two methods for guiding breast cancer surgery

Randomized Prospective Trial of Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer

Not applicable Interventional CairnSurgical, Inc. · NCT04397185

This study is testing a new way to guide breast cancer surgery using a special imaging tool to see if it works as well as the traditional method for women with certain types of breast cancer.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment448 (estimated)
Ages18 Years and up
SexFemale
SponsorCairnSurgical, Inc. Industry-sponsored
Drugs / interventionschemotherapy
Locations26 sites (Scottsdale, Arizona and 25 other locations)
Trial IDNCT04397185 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of the Breast Cancer Locator (BCL) compared to traditional wire localization (WL) for guiding partial mastectomy in women with non-palpable invasive breast cancer or ductal carcinoma in situ (DCIS). Participants will be randomly assigned to receive either BCL or WL during their surgery. The BCL system provides a three-dimensional image of the tumor, allowing surgeons to visualize critical distances and mark tumor edges accurately. The goal is to determine if the BCL is as safe and effective as the standard WL method in achieving clear surgical margins.

Who should consider this trial

Good fit: Ideal candidates are females over 18 years old with a histologic diagnosis of invasive breast cancer or DCIS requiring pre-operative tumor localization.

Not a fit: Patients with contraindications to MRI or severe claustrophobia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced recurrence rates for patients with non-palpable breast cancer.

How similar studies have performed: Previous studies have shown promising results with similar localization techniques, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Female gender
* Age \> 18 years
* Histologic diagnosis of invasive breast cancer or DCIS
* The surgeon determines that pre-operative tumor localization is required because the tumor cannot be definitively detected by palpation
* The tumor is unifocal or multifocal with satellite lesions \< or = 2 cm from primary tumor
* The tumor enhances on prone breast MRI imaging
* The tumor is ≥ 1 cm in diameter on prone breast MRI
* Subject and surgeon agree to perform BCS
* Subject voluntarily provides informed consent

Exclusion Criteria:

* Absolute contraindication to MRI, including presence of implanted electrical device (e.g., pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes
* Severe claustrophobia that precludes prone or supine MRI
* Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy
* Compromised renal function including chronic, severe kidney disease (GFR \< 30 ml/min/1.73m2), or acute kidney injury
* Pregnancy - In women of childbearing potential, a urine pregnancy test will be performed
* Subjects who have received or plan to receive neoadjuvant chemotherapy
* Sternal notch to nipple distance of \> 32 cm as measured in a sitting or standing position
* Measurement of widest circumference around breasts and arms \> 135 cm for sites using 60cm bore scanners, and measurement of widest circumference around breasts and arms \>145 cm for sites using 70 cm bore scanners
* Subjects with known allergy to materials present in the device
* Use of localization with devices other than a localization wire, including intraoperative ultrasound guidance, radiofrequency emitting implants, magnetic seeds, radioactive seeds, and tissue inspection devices (MarginProbe)
* Subject would require \> 2 localization wires, if randomized to standard of care
* Subjects with multicentric tumors (additional tumors \> 2 cm from primary)
* Subject would require chest wall muscle nerve block as part of the operation

Where this trial is running

Scottsdale, Arizona and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast Cancer Female
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.