Breast Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 mammography or prone 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

Study is for people with:

Breast Cancer

Estimated Enrollment:

448

Study ID:

NCT04397185

Recruitment Status:

Recruiting

Sponsor:

CairnSurgical, Inc.

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There are 23 Locations for this study

See Locations Near You

Arizona Center for Cancer Care
Scottsdale Arizona, 85258, United States More Info
Penny Labriola
Contact
480-278-8261
[email protected]
Sommer R. Gunia, DO
Principal Investigator
Baptist MD Anderson Cancer Center
Jacksonville Florida, 32207, United States More Info
Dana Kontras, MSN, RN
Contact
904-202-7070
[email protected]
Laila Samiian, MD
Principal Investigator
Moffitt Cancer Center
Tampa Florida, 33612, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
Mass General/North Shore Center for Outpatient Care
Danvers Massachusetts, 01923, United States
Steward Medical Group
Easton Massachusetts, 02356, United States
Hennepin Healthcare
Minneapolis Minnesota, 55415, United States More Info
Emily Colonna
Contact
[email protected]
Abigail Madans, DO
Principal Investigator
Cheshire Medical Center
Keene New Hampshire, 03431, United States More Info
Erin Lynch
Contact
H.E. Guy Burman, MD
Principal Investigator
Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03766, United States
Catholic Medical Center
Manchester New Hampshire, 03102, United States
St. Joseph Hospital
Nashua New Hampshire, 03060, United States More Info
Alison Gnerre, RN
Contact
603-884-4171
[email protected]
Stacey Abbis, MD
Principal Investigator
Summit Health
Florham Park New Jersey, 07932, United States More Info
Romilda Moreira
Contact
[email protected]
Winnie Polen, DO
Principal Investigator
St. Peter's Hospital
Albany New York, 12208, United States More Info
Khadija Rafiqi
Contact
518-525-6739
[email protected]
Sarah Pesek, MD
Principal Investigator
Kings County Hospital Center
Brooklyn New York, 11207, United States
Columbia University Irving Medical Center and New York-Presbyterian Hospital
New York New York, 10032, United States
Montefiore Nyack Hospital
Nyack New York, 10960, United States
The Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43212, United States
Women and Infants Hospital
Providence Rhode Island, 02905, United States
Kent Hospital
Warwick Rhode Island, 02886, United States More Info
Jessica Rotondo, MBA
Contact
401-737-7000
[email protected]
Jamie Patterson, MD
Principal Investigator
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Chantell M Farinas
Contact
713-563-4560
[email protected]
Kelly Hunt, MD
Principal Investigator
Southwestern Vermont Medical Center
Bennington Vermont, 05201, United States
Rutland Regional Medical Center
Rutland Vermont, 05701, United States
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Royal Free London NHS Trust
London , , United Kingdom
Manchester University NHS
Manchester , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

448

Study ID:

NCT04397185

Recruitment Status:

Recruiting

Sponsor:


CairnSurgical, Inc.

How clear is this clinincal trial information?

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