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

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04397185
• Other study ID #: BCL IDE
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2020
• Est. completion date: April 2025

Study information

• Verified date: June 2024
• Source: CairnSurgical, Inc.
• Contact: Jodie Ploetz, MA
• Phone: 303-656-0560
• Email: jploetz[@]cairnsurgical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 448
• Est. completion date: April 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 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:

• 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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

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.
• Wire Localized (WL) partial mastectomy
Standard of care procedure

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
United Kingdom	Royal Free London NHS Trust	London
United Kingdom	Manchester University NHS	Manchester
United States	St. Peter's Hospital	Albany	New York
United States	Southwestern Vermont Medical Center	Bennington	Vermont
United States	Tufts Medical Center	Boston	Massachusetts
United States	Kings County Hospital Center	Brooklyn	New York
United States	The Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Mass General/North Shore Center for Outpatient Care	Danvers	Massachusetts
United States	Steward Medical Group	Easton	Massachusetts
United States	Summit Health	Florham Park	New Jersey
United States	MD Anderson Cancer Center	Houston	Texas
United States	Baptist MD Anderson Cancer Center	Jacksonville	Florida
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	Hennepin Healthcare	Minneapolis	Minnesota
United States	St. Joseph Hospital	Nashua	New Hampshire
United States	Columbia University Irving Medical Center and New York-Presbyterian Hospital	New York	New York
United States	Montefiore Nyack Hospital	Nyack	New York
United States	Women and Infants Hospital	Providence	Rhode Island
United States	Rutland Regional Medical Center	Rutland	Vermont
United States	Arizona Center for Cancer Care	Scottsdale	Arizona
United States	Moffitt Cancer Center	Tampa	Florida
United States	Kent Hospital	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
CairnSurgical, Inc.

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive margin rate	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	At completion of study recruitment, approximately 18 months after first subject enrolled
Secondary	Specimen volumes	To compare specimen volumes for women randomized to BCL vs. WL-guided BCS	At completion of study recruitment, approximately 18 months after first subject enrolled
Secondary	Re-excision rate	To compare re-excision rate for women randomized to BCL vs. WL-guided BCS	At completion of study recruitment, approximately 18 months after first subject enrolled
Secondary	Cancer localization rate	To compare cancer localization rate for women randomized to BCL vs. WL-guided BCS	At completion of study recruitment, approximately 18 months after first subject enrolled
Secondary	Operative times	To compare operative times for women randomized to BCL vs. WL-guided BCS	At completion of study recruitment, approximately 18 months after first subject enrolled
Secondary	Adverse event rate	To compare adverse event rate for women randomized to BCL vs. WL-guided BCS	At completion of study recruitment, approximately 18 months after first subject enrolled
Secondary	Rate of additional shave biopsies	To compare rate of additional shave biopsies for women randomized to BCL vs. WL-guided BCS	At completion of study recruitment, approximately 18 months after first subject enrolled
Secondary	Costs of care	To compare costs of care for women randomized to BCL vs. WL-guided BCS	At completion of study recruitment, approximately 18 months after first subject enrolled