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Clinical Trial

The reality is that breast conserving surgery is unsuccessful in removing the entire tumors in 1 out of 5 cases. Removal of the remaining tumor typically requires repeating the surgery.

A new clinical trial is studying if the investigational Breast Cancer Locator (BCL™) System used during surgery can help surgeons achieve the primary objective of reducing positive margins.

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The Breast Cancer Locator (BCL™) System Clinical Trial

The Breast Cancer Locator™ Trial is a prospective, multicenter, 1:1, randomized, controlled pivotal trial of the BCL™ System. The BCL™ System is used to guide tumor removal for breast cancer compared to traditional wire localization.

To learn more about the trial visit ClinicalTrials.gov

Who is the Right Candidate?

Key inclusion criteria

Tumor >1 cm in diameter visible on prone breast MRI imaging

Non-palpable, unifocal tumor or multifocal tumor with satellite lesions ≤ 2cm from primary tumor

Histologic diagnosis of invasive breast cancer or DCIS

Women over 18 years old

Key exclusion criteria

  • Absolute contraindication to MRI, including presence of implanted medical device (e.g., pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes
  • Contraindication to use of gadolinium-based intravenous contrast, including life-threatening allergy
  • Severe claustrophobia that precludes prone or supine MRI
  • Compromised renal function, including chronic, severe kidney disease or acute kidney injury
  • Pregnancy
  • Previous or planned neoadjuvant chemotherapy
  • Sternal notch-to-nipple distance of > 32cm
  • > 135cm circumference around breasts and arms for sites using 60cm bore scanners, and >145 cm for sites using 70cm bore scanners
  • Known allergy to materials in device
  • Use of localization with devices other than a localization wire
  • Would require >2 localization wires, if randomized to standard of care arm
  • Multicentric tumors (additional tumors > 2cm from primary tumor)
  • Would require chest wall muscle nerve block as part of the operation

Breast Cancer Locator™ Trial Centers

Locations

Dartmouth-Hitchcock Nashua
St. Joseph Hospital Rehabilitation
2300 Southwood Drive
Nashua, NH 03063
Ph: 603.577.4171

Catholic Medical Center – Breast Care Center
Bedford Medical Park
9 Washington Place
Bedford, NH 03110
Ph: 603.663.5270

Massachusetts General/North Shore Center for Outpatient Care
104 Endicott Street, Suite 200
Danvers, MA 01923
Ph: 978.882.6899

Moffitt Cancer Center Magnolia Campus
12902 USF Magnolia Drive
Tampa, FL 33612
Ph: 813.745.4673

Kent Hospital
455 Toll Gate Rd
Warwick, RI 02886
Ph: 401.737.7000

Manchester University NHS Foundation Trust
1st Floor NOWGEN Centre
Nightingale Centre Southmoor Road
Manchester M239LT
0300 33 9444

Princess Margaret Cancer Centre
University Health Network – PMH
610 University Ave, 3-130
Toronto, Ontario Canada, M5G 2M9
Ph: 416.946.2292

MD Anderson Cancer Center
Breast Surgical Oncology
1400 Pressler Unit 1434
Houston, TX 77030-4008
Ph: 713.792.5031

Baptist MD Anderson Cancer Center
1301 Palm Avenue
Jacksonville, FL 32207
Ph: 904.202.7070

Comprehensive Breast Center
A Division of Arizona Center for Cancer Care
9965 N. 95th
St, Suite 105
Scottsdale, AZ 85258
Ph: 480.278.8261

St Peter’s Health Partners Cancer Care Center
317 South Manning Boulevard, Suite 220
Albany, New York 12208
Ph: 518.525.6739

Hennepin Healthcare
701 Park Ave
Minneapolis,
MN 55415
Ph: 612.873.5300

Tufts University
860 Washington St
Boston,
MA 02111

Columbia University Irving Medical Center and New York-Presbyterian Hospital
161 Fort Washington Avenue
New York, NY 10032
Ph: 212.305.9676

Women and Infants Program in Women’s Oncology Breast Health Center
101 Dudley Street
Providence, RI 02905
Ph: 401.453.7540

Norris Cotton Cancer Center
Dartmouth-Hitchcock Medical Center
One Medical Center Drive
Lebanon, NH 03756-3500
Ph: 603.650.4344

Cheshire Medical Center Dartmouth-Hitchcock Keene General Surgery
580 Court St
Keene, NH 03431
Ph: 603.354.5469

Royal Free Hospital
Pond St
London NW3 2QG,
United Kingdom
Ph: +44.20.7794.0500

The Ohio State University Comprehensive Cancer Center
460 W. 10th Avenue
Columbus, OH 43212
Ph: 614.293.4040

Summit Health
150 Park Ave
Florham Park, NJ 07932
Ph: 970.404.9945

BASS Medical Group
575 Lennon Ln, Suite 153
Walnut Creek, CA 94598
Ph: 925.433.6005

To learn more about the clinical trial

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