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

NCT04397185 | Completed DMC FDA Device

• 1 other identifier: BCL IDE
• Study Type: interventional
• Target: 480
• Locations: 4 countries
• Sites: 23

Brief Summary

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.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Specimen volumes

  At completion of study recruitment, approximately 18 months after first subject enrolled

• Re-excision rate

  At completion of study recruitment, approximately 18 months after first subject enrolled

• Cancer localization rate

  At completion of study recruitment, approximately 18 months after first subject enrolled

• Operative times

  At completion of study recruitment, approximately 18 months after first subject enrolled

• Adverse event rate

  At completion of study recruitment, approximately 18 months after first subject enrolled

Study Arms (2)

Breast Cancer Locator (BCL)

EXPERIMENTAL

Subject randomized to BCL surgical guidance to perform partial mastectomy

Device: Breast Cancer Locator (BCL) guided partial mastectomy

Wire Localization (WL)

ACTIVE COMPARATOR

Subject randomized to WL surgical guidance to perform partial mastectomy

Device: Wire Localized (WL) partial mastectomy

Interventions

Wire Localized (WL) partial mastectomy DEVICE

Standard of care procedure

Wire Localization (WL)

Breast Cancer Locator (BCL) guided partial mastectomy DEVICE

The BCL is a patient-specific, plastic, bra-like form which is placed on the breast to localize the tumor during surgery.

Breast Cancer Locator (BCL)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CairnSurgical, Inc.: lead

Study Sites (23)

Arizona Center for Cancer Care

Scottsdale, Arizona, 85258, United States

Location

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Mass General/North Shore Center for Outpatient Care

Danvers, Massachusetts, 01923, United States

Location

Steward Medical Group

Easton, Massachusetts, 02356, United States

Location

Hennepin Healthcare

Minneapolis, Minnesota, 55415, United States

Location

Cheshire Medical Center

Keene, New Hampshire, 03431, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

St. Joseph Hospital

Nashua, New Hampshire, 03060, United States

Location

Summit Health

Florham Park, New Jersey, 07932, United States

Location

St. Peter's Hospital

Albany, New York, 12208, United States

Location

Columbia University Irving Medical Center and New York-Presbyterian Hospital

New York, New York, 10032, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Kent Hospital

Warwick, Rhode Island, 02886, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Rutland Regional Medical Center

Rutland, Vermont, 05701, United States

Location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

LKH Feldkirch

Feldkirch, Austria

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Basildon University Hospital

Basildon, United Kingdom

Location

Manchester University NHS

Manchester, United Kingdom

Location

MeSH Terms

Interventions

Mastectomy, Segmental

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Officials

• Jennifer Gass, MD

  Women & Infants Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Pathologist will be blinded to the study assignment (BCL vs. WL)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 21, 2020
• Study Start: December 23, 2020
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

CA (1); GB (2); AU (1); US (19)