Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer
NCT ID: NCT04397185
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
480 participants
INTERVENTIONAL
2020-12-23
2025-12-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Breast Cancer Locator (BCL)
Subject randomized to BCL surgical guidance to perform partial mastectomy
Breast Cancer Locator (BCL) guided partial mastectomy
The BCL is a patient-specific, plastic, bra-like form which is placed on the breast to localize the tumor during surgery.
Wire Localization (WL)
Subject randomized to WL surgical guidance to perform partial mastectomy
Wire Localized (WL) partial mastectomy
Standard of care procedure
Interventions
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Wire Localized (WL) partial mastectomy
Standard of care procedure
Breast Cancer Locator (BCL) guided partial mastectomy
The BCL is a patient-specific, plastic, bra-like form which is placed on the breast to localize the tumor during surgery.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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CairnSurgical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jennifer Gass, MD
Role: PRINCIPAL_INVESTIGATOR
Women & Infants Hospital
Locations
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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
Countries
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Other Identifiers
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BCL IDE
Identifier Type: -
Identifier Source: org_study_id
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