Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer
- Conditions
- Breast Cancer Female
- Interventions
- Device: Wire Localized (WL) partial mastectomyDevice: Breast Cancer Locator (BCL) guided partial mastectomy
- Registration Number
- NCT04397185
- Lead Sponsor
- CairnSurgical, Inc.
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 448
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Wire Localization (WL) Wire Localized (WL) partial mastectomy Subject randomized to WL surgical guidance to perform partial mastectomy Breast Cancer Locator (BCL) Breast Cancer Locator (BCL) guided partial mastectomy Subject randomized to BCL surgical guidance to perform partial mastectomy
- Primary Outcome Measures
Name Time Method Positive margin rate At completion of study recruitment, approximately 18 months after first subject enrolled 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
- Secondary Outcome Measures
Name Time Method Rate of additional shave biopsies At completion of study recruitment, approximately 18 months after first subject enrolled To compare rate of additional shave biopsies for women randomized to BCL vs. WL-guided BCS
Costs of care At completion of study recruitment, approximately 18 months after first subject enrolled To compare costs of care for women randomized to BCL vs. WL-guided BCS
Re-excision rate At completion of study recruitment, approximately 18 months after first subject enrolled To compare re-excision rate for women randomized to BCL vs. WL-guided BCS
Specimen volumes At completion of study recruitment, approximately 18 months after first subject enrolled To compare specimen volumes for women randomized to BCL vs. WL-guided BCS
Operative times At completion of study recruitment, approximately 18 months after first subject enrolled To compare operative times for women randomized to BCL vs. WL-guided BCS
Adverse event rate At completion of study recruitment, approximately 18 months after first subject enrolled To compare adverse event rate for women randomized to BCL vs. WL-guided BCS
Cancer localization rate At completion of study recruitment, approximately 18 months after first subject enrolled To compare cancer localization rate for women randomized to BCL vs. WL-guided BCS
Trial Locations
- Locations (26)
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Hennepin Healthcare
🇺🇸Minneapolis, Minnesota, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Rutland Regional Medical Center
🇺🇸Rutland, Vermont, United States
BASS Medical Group
🇺🇸Walnut Creek, California, United States
Arizona Center for Cancer Care
🇺🇸Scottsdale, Arizona, United States
Baptist MD Anderson Cancer Center
🇺🇸Jacksonville, Florida, United States
Steward Medical Group
🇺🇸Easton, Massachusetts, United States
Cheshire Medical Center
🇺🇸Keene, New Hampshire, United States
Catholic Medical Center
🇺🇸Manchester, New Hampshire, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Mass General/North Shore Center for Outpatient Care
🇺🇸Danvers, Massachusetts, United States
St. Joseph Hospital
🇺🇸Nashua, New Hampshire, United States
Kent Hospital
🇺🇸Warwick, Rhode Island, United States
Summit Health
🇺🇸Florham Park, New Jersey, United States
The Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Montefiore Nyack Hospital
🇺🇸Nyack, New York, United States
Columbia University Irving Medical Center and New York-Presbyterian Hospital
🇺🇸New York, New York, United States
Kings County Hospital Center
🇺🇸Brooklyn, New York, United States
Women and Infants Hospital
🇺🇸Providence, Rhode Island, United States
Royal Free London NHS Trust
🇬🇧London, United Kingdom
Manchester University NHS
🇬🇧Manchester, United Kingdom
St. Peter's Hospital
🇺🇸Albany, New York, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Southwestern Vermont Medical Center
🇺🇸Bennington, Vermont, United States