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Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer
Trial Status: complete
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.
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04397185.
Locations matching your search criteria
United States
Massachusetts
Danvers
Mass General/North Shore Cancer Center
Status: Temporarily closed to accrual
Name Not Available
New Hampshire
Lebanon
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Status: Temporarily closed to accrual
Name Not Available
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available
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
