NCT04397185

Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer

Randomized Prospective Trial of Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: CairnSurgical, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer Female

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	Wire Localized (WL) partial mastectomy	Standard of care procedure

Timeline

• Start date: 2020-12-23
• Primary completion: 2025-12-09
• Completion: 2025-12-09
• First posted: 2020-05-21
• Last updated: 2026-01-20

Locations

23 sites across 4 countries: United States, Austria, Canada, United Kingdom

Regulatory

• FDA-regulated device study