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

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: Completed
• Conditions: Breast Cancer Female
• Intervention / Treatment: Device: Breast Cancer Locator (BCL) guided partial mastectomy; Device: Wire Localized (WL) partial mastectomy

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: Interventional
• Enrollment (Actual): 480
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Positive margin rate	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

Outcome Measure	Measure Description	Time Frame
Specimen volumes	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	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	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	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	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	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	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

• Sponsor: CairnSurgical, Inc.
• Investigators: Principal Investigator: Jennifer Gass, MD, Women & Infants Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2020
• Primary Completion (Actual): December 9, 2025
• Study Completion (Actual): December 9, 2025

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Surgical Procedures, Operative; Mastectomy; Mastectomy, Segmental
• Other Study ID 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