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

  • STATUS
    Recruiting
  • End date
    Oct 29, 2022
  • participants needed
    448
  • sponsor
    CairnSurgical, Inc.
Updated on 29 December 2021

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.

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.

Details
Condition Breast Cancer Female
Treatment Breast Cancer Locator (BCL) guided partial mastectomy, Wire Localized (WL) partial mastectomy
Clinical Study IdentifierNCT04397185
SponsorCairnSurgical, Inc.
Last Modified on29 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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; possible satellite lesions < 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

Exclusion Criteria

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
Contraindication to use of gadolinium-based intravenous contrast, including lifethreatening 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)
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