Providence, RI – Results from a large clinical trial involving Care New England’s Women & Infants and Kent Hospitals, along with 22 other centers across the US, Canada, the UK, and Austria, demonstrated a promising new approach that may make breast cancer surgery more precise and effective.
Dr. Jennifer Gass, Director of the Breast Health Center, Care New England, and Principal Investigator, led a study comparing the Breast Cancer Locator (BCL) System to conventional methods used for tumor localization in patients undergoing lumpectomy surgery. Partially conducted at the Breast Health Center at Women & Infants and Kent Hospitals, the study demonstrated that the BCL significantly improved surgeons’ ability to remove the complete tumor with no presence of cancer at the margins of excised tissue and decreased the need for additional surgeries. Results were presented at the annual meeting of the American Society of Breast Surgeons.
Despite the best efforts of surgeons and radiologists, cancer is left behind following lumpectomy surgery in about 20-25% of all cases in the U.S. each year, requiring a second surgery to remove it completely.
“Breast cancers commonly have an irregular shape, and this study was designed to determine if giving the surgeon a more precise image of the tumor size and shape using a customized guidance device might enable more successful surgeries,” said Dr. Gass. “The BCL technology enabled us to define the precise location and boundaries of even the most difficult tumors, and to view tumors in 3D before and during surgery. This detailed tumor guidance is information that has been missing with other methods until now.”
“Care New England’s Breast Health Center at Women & Infants and Kent Hospitals is proud to be part of this important research, which demonstrates our commitment to fighting and treating breast cancer in every patient who needs care,” said Dr. Gass.
Clinical Trial Highlights
The Breast Cancer Locator (BCL) Trial encompassed 418 patients in the US, Canada, the UK, and Austria with non-palpable invasive breast cancer or DCIS treated with the BCL System or with conventional “wire localization” to identify tumor location.
In the study, the following observations were made in comparing the BCL System to conventional wire localization:
• 32% reduction in the positive margin rate (PMR) - the rate of cancer being found at the edge of the excision following surgery – across all patients
• 34% reduction in the re-excision rate - or second surgeries - across all patients
• Comparable safety profile
The foundation of the Breast Cancer Locator (BCL) System is an MRI taken with the patient lying face-up, in the same position as surgery, to obtain the most accurate view of the tumor shape, size, and location. The Breast Cancer Locator (BCL) System is then 3D-printed using the MRI imaging data to create a customized, breast-shaped device matching the unique shape of a patient’s breast and the unique location and shape of the tumor. At the start of surgery, the BCL is placed on a patient’s breast, and a surgeon uses ports in the device to guide them to the precise tumor margins during excision. The tumor is also viewable in 3D before and during surgery.
The Breast Cancer Locator is considered an investigational device in the U.S. and is limited by U.S. law to investigational use only.
About Women & Infants Hospital
Women & Infants Hospital of Rhode Island, a Care New England hospital, is one of the nation’s leading specialty hospitals for women and newborns. A major teaching affiliate of The Warren Alpert Medical School of Brown University for obstetrics, gynecology, and newborn pediatrics, as well as a number of specialized programs in women’s medicine, Women & Infants is the ninth largest stand-alone obstetrical service in the country and the largest in New England with approximately 8,700 deliveries per year. Women & Infants is a Designated Baby-Friendly® USA hospital and was recently ranked by Newsweek as one of America's Best Maternity Hospitals in 2024. The Department of Obstetrics and Gynecology ranked 11 in U.S. News & World Report’s 2019 Best Medical Schools specialty ranking.
Women & Infants has been designated as a Breast Imaging Center of Excellence by the American College of Radiography; a Center of Excellence in Minimally Invasive Gynecology; and a Neonatal Resource Services Center of Excellence. It is one of the largest and most prestigious research facilities in high-risk and normal obstetrics, gynecology, and newborn pediatrics in the nation, and is a member of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal Fetal Medicine Units Network, and Pelvic Floors Disorders Network, as well as the National Cancer Institute’s Gynecologic Oncology Group.
About Kent Hospital
Kent Hospital, a Care New England facility, is a 359-bed, acute care hospital. It ranks as Rhode Island’s second-largest hospital, serving around 300,000 residents in central Rhode Island. As a teaching affiliate of The Warren Alpert Medical School of Brown University and The University of New England College of Osteopathic Medicine, Kent provides training programs in emergency medicine, family medicine, internal medicine, podiatry, diabetology, and gastroenterology. Its Emergency Department (ED), classified as a high-volume ED by CMS, handles roughly 55,000 patients annually and is one of four hospitals in Rhode Island offering emergency angioplasty for heart attacks. Additionally, it has been recognized as a verified geriatric surgery facility by the American College of Surgeons Geriatric Surgery Verification (GSV) program—the first hospital in New England and the 25th nationwide to earn this distinction. Kent Hospital also maintains a longstanding clinical partnership with Boston’s Brigham and Women’s Hospital, providing excellent local care for conditions like cardiology, pulmonary issues, thoracic surgery, colorectal surgery, and other specialties. The hospital is dedicated to becoming age-friendly to deliver top-quality care for older adults. Its Silver-Level 2 Geriatric ED Accreditation, Geriatric Surgery Comprehensive Excellence Verification, and Acute Care for Elders (ACE) unit exemplifies Kent’s commitment to Healthy Aging and managing issues affecting the health and well-being of the aging community.
About Care New England
Care New England Health System is a trusted organization advancing the future of care through leading medical research, nationally recognized clinical services, and innovative programs. As one connected system, CNE attracts top, specially trained physicians and clinicians, fosters collaboration across disciplines, and leads meaningful conversations about health, wellness, and end-of-life care.
Founded in 1996, Care New England brings together a network of respected organizations working together to better serve patients and the community. The system includes Butler Hospital, Kent Hospital, Women & Infants Hospital, Care New England Medical Group, VNA Home Health and Hospice, The Providence Center, and Integra, a certified accountable care organization (ACO). Care New England includes 749 licensed beds and 102 infant bassinets. Care New England is proud of its strong commitment to education and research, and through Butler, Kent, and Women & Infants Hospitals, maintains a teaching and research affiliation with The Warren Alpert Medical School of Brown University. Kent is also a teaching affiliate of the University of New England College of Osteopathic Medicine.
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