Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer

January 16, 2026 updated by: CairnSurgical, Inc.

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

This prospective, multicenter, 1:1 randomized, controlled trial is designed to evaluate the safety and effectiveness of the Breast Cancer Locator (BCL) in subjects with non-palpable invasive breast cancer or ductal carcinoma in situ (DCIS). Subjects will be randomized to breast conserving surgery (BCS) utilizing either the BCL or wire localization (WL) to guide surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The BCL System is intended to be used to guide a surgeon when performing partial mastectomy for breast cancer and to minimize positive margins. The purpose of this study is to provide evidence that the BCL is safe, effective, and non-inferior to the standard of care (WL) in the removal of non-palpable invasive breast cancer and DCIS.

Investigators in the intervention group will be provided with a three dimensional (3D) image of the cancer in the breast which allows them to visualize the closest distance from the tumor to the skin and the chest wall and quantifies those distances. Investigators will also use a BCL, which is a patient specific, plastic, bra-like form that is transiently placed on the breast prior to surgery and allows the Investigator to mark the projected edges of the tumor on the breast skin and to place bracketing wires inside the breast which define the center of the cancer and distances 1 cm from the tumor edges defined by pre-operative supine MRI.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
480

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Austria
      • Feldkirch, Austria
        • LKH Feldkirch
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
  • United Kingdom
      • Basildon, United Kingdom
        • Basildon University Hospital
      • Manchester, United Kingdom
        • Manchester University NHS
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Arizona Center for Cancer Care
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist MD Anderson Cancer Center
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Danvers, Massachusetts, United States, 01923
        • Mass General/North Shore Center for Outpatient Care
      • Easton, Massachusetts, United States, 02356
        • Steward Medical Group
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin Healthcare
    • New Hampshire
      • Keene, New Hampshire, United States, 03431
        • Cheshire Medical Center
      • Lebanon, New Hampshire, United States, 03766
        • Dartmouth-Hitchcock Medical Center
      • Manchester, New Hampshire, United States, 03102
        • Catholic Medical Center
      • Nashua, New Hampshire, United States, 03060
        • St. Joseph Hospital
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
        • Summit Health
    • New York
      • Albany, New York, United States, 12208
        • St. Peter's Hospital
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center and New York-Presbyterian Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital
      • Warwick, Rhode Island, United States, 02886
        • Kent Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Vermont
      • Rutland, Vermont, United States, 05701
        • Rutland Regional Medical Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Breast Cancer Locator (BCL)
Subject randomized to BCL surgical guidance to perform partial mastectomy
Device: Breast Cancer Locator (BCL) guided partial mastectomy
The BCL is a patient-specific, plastic, bra-like form which is placed on the breast to localize the tumor during surgery.
Active Comparator: Wire Localization (WL)
Subject randomized to WL surgical guidance to perform partial mastectomy
Device: Wire Localized (WL) partial mastectomy
Standard of care procedure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Positive margin rate
Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled
To provide evidence that the positive margin rate following BCS using the BCL is not inferior to the standard of care (WL) for surgical guidance
At completion of study recruitment, approximately 18 months after first subject enrolled

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Specimen volumes
Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled
To compare specimen volumes for women randomized to BCL vs. WL-guided BCS
At completion of study recruitment, approximately 18 months after first subject enrolled
Re-excision rate
Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled
To compare re-excision rate for women randomized to BCL vs. WL-guided BCS
At completion of study recruitment, approximately 18 months after first subject enrolled
Cancer localization rate
Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled
To compare cancer localization rate for women randomized to BCL vs. WL-guided BCS
At completion of study recruitment, approximately 18 months after first subject enrolled
Operative times
Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled
To compare operative times for women randomized to BCL vs. WL-guided BCS
At completion of study recruitment, approximately 18 months after first subject enrolled
Adverse event rate
Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled
To compare adverse event rate for women randomized to BCL vs. WL-guided BCS
At completion of study recruitment, approximately 18 months after first subject enrolled
Rate of additional shave biopsies
Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled
To compare rate of additional shave biopsies for women randomized to BCL vs. WL-guided BCS
At completion of study recruitment, approximately 18 months after first subject enrolled
Costs of care
Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled
To compare costs of care for women randomized to BCL vs. WL-guided BCS
At completion of study recruitment, approximately 18 months after first subject enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CairnSurgical, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer Gass, MD, Women & Infants Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 23, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 9, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 9, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BCL IDE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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