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

Completed · Not applicable

Conditions studied: Breast Cancer Female

In brief

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.

Key facts

Study ID

NCT04397185

Run by

CairnSurgical, Inc.

People needed

480

Starts

2020-12-23

Expected to finish

2025-12-09

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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