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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; possible satellite lesions ≤ 2cm from primary are eligible

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
  • 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
  • Known allergy to materials in device
  • Use of localization with devices other than a localization wire
  • Multicentric tumors (additional tumors > 2cm from primary tumor)

Breast Cancer Locator™ Trial Centers

Locations

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

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

3. Cheshire Medical Center Dartmouth-Hitchcock Keene General Surgery 580 Court St
Keene, NH 03431
Ph: 603.354.5400

4. Dartmouth-Hitchcock Nashua, St. Joseph Hospital Rehabilitation St. Joseph Hospital Rehabilitation
2300 Southwood Drive
Nashua, NH 03063
Ph: 603.577.4141

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

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

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

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

9. Baptist MD Anderson Cancer Center 1301 Palm Avenue
Jacksonsville, FL 32207
Ph: 844.632.2278

10. St. Peter’s Health Partners Cancer Care Center 317 South Manning Boulevard, Suite 220
Albany, New York 12208
Ph: 518.525.6418

11. Kent Hospital 455 Toll Gate Rd
Warwick, RI 02886
Ph: 401.737.7000 x31857

12. Royal Free Hospital Pond St
London NW3 2QG,
United Kingdom

13. Manchester University NHS Foundation Trust Research Office,
1 st Floor NOWGEN Centre
Nightingale Centre Southmoor Road
Manchester M239LT

14. Hennepin Healthcare 701 Park Ave
Minneapolis,
MN 55415

15. UC San Diego Moores Cancer Center 3855 Health Sciences Dr
La Jolla, CA
92093-0698

16. Montefiore Nyack Breast Center 160 North Midland Ave
Nyack,
NY 10960

17. Tufts University 860 Washington St
Boston,
MA 02111

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

19. Summit Health 150 Park Ave
Florham Park, NJ  07932

20. Steward Medical Group 15 Roche Brother’s Way, Suite 220
Easton, MA  02356

To learn more about the clinical trial

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