Breast Cancer Clinical Trial
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.
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.
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; possible satellite lesions < or = 2 cm from primary are eligible
The tumor enhances on prone breast MRI imaging
The tumor is ≥ 1 cm in diameter on mammography or prone MRI
Subject and surgeon agree to perform BCS
Ability to voluntarily provide informed consent
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
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 age 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
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
Multicentric tumors (additional tumors > 2 cm from primary)
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 20 Locations for this study
Scottsdale Arizona, 85258, United States
Jacksonville Florida, 32207, United States
Tampa Florida, 33612, United States
Boston Massachusetts, 02111, United States
Danvers Massachusetts, 01923, United States
Easton Massachusetts, 02356, United States
Minneapolis Minnesota, 55415, United States
Keene New Hampshire, 03431, United States
Lebanon New Hampshire, 03766, United States
Manchester New Hampshire, 03102, United States
Nashua New Hampshire, 03060, United States
Florham Park New Jersey, 07932, United States
Albany New York, 12208, United States
New York New York, 10032, United States
Columbus Ohio, 43212, United States
Providence Rhode Island, 02905, United States
Warwick Rhode Island, 02886, United States
Houston Texas, 77030, United States
Rutland Vermont, 05701, United States
Toronto Ontario, M5G 2, Canada
London , , United Kingdom
Manchester , , United Kingdom
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.