Status:
ACTIVE_NOT_RECRUITING
Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer
Lead Sponsor:
CairnSurgical, Inc.
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ca...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
448 Patients enrolled
Trial Details
Trial ID
NCT04397185
Start Date
December 23 2020
End Date
December 1 2025
Last Update
October 31 2025
Active Locations (23)
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1
Arizona Center for Cancer Care
Scottsdale, Arizona, United States, 85258
2
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
Tufts Medical Center
Boston, Massachusetts, United States, 02111