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BCRF-Supported Breast Screening Trial Aims to Improve Early Detection for Women with Dense Breasts

An upcoming clinical trial will evaluate the use of contrast enhanced mammography as a breast cancer screening option for women with dense breast tissue
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About 40 percent of women over the age of 40 have dense breasts. The condition, characterized by relatively high amounts of glandular tissue and fibrous connective tissue and low amounts of fatty breast tissue, can make reading and detecting breast cancer on a mammogram difficult. It’s a challenge that BCRF researchers want to meet head-on. Current guidelines call for supplemental screening with whole breast ultrasound (WBUS), however, this can result in false positives, as does screening with MRI.

“Women with dense breasts need better and more accurate screening options than what is currently available,” said Dorraya El-Ashry, PhD, BCRF Chief Scientific Officer. “Early detection remains key to improving breast cancer outcomes and our collective goal is to optimize critical tools for diagnosis.”

In an effort to improve early breast cancer detection and reduce false positive exams in women with dense breasts, BCRF is launching a groundbreaking study. Seeded by The Lampert Foundation, BCRF along with the American College of Radiology (ACR) and GE Healthcare are partnering to support the Contrast Enhanced Mammography Imaging Screening Trial (CMIST).

The planned clinical trial, managed by the ACR Center for Research and Innovation, seeks to validate early positive findings that contrast enhanced spectral mammography (CESM) screening provides more accurate cancer detection compared to combination of digital breast tomosynthesis (DBT) and whole breast ultrasound (WBUS) in women with dense breasts.

“CMIST will investigate the challenges of current screening options for women with dense breasts,” said Dr. El-Ashry. “The goal is to reduce false positive rates while improving breast cancer detection.”

CESM combines mammography and vascular-based screening methods that may offer a more efficient screening approach. The technology highlights areas of unusual blood flow patterns in a simple and quick procedure. Early studies of CESM in screening women with dense breasts have shown that CESM has the potential to increase the breast cancer detection rate by 70-80% compared to conventional mammography.

Trial sites have yet to be confirmed for the multicenter clinical trial that is expected to launch in spring 2020. Participants will have mammographically dense breasts – defined as a BI-RADS density categories C and D – be between the ages 40-75, at average-to-intermediate risk for breast cancer. The performance of CESM will be evaluated in screening women with dense breasts compared to the combination of tomosynthesis and ultrasound.

“The trial can help determine if CESM can provide a more accurate and efficient screening approach for women with dense breasts,” said CMIST Principal Investigator Christopher Comstock, MD, FACR, FSBI, director of breast imaging clinical trials, Memorial Sloan Kettering Cancer Center.

While current supplemental screening modestly improves breast cancer detection, it takes more time, has a high false positive rate, and can increase breast biopsies and costs. Results from the CMIST trial may provide a new avenue for women with dense breasts.

“We know that one size does not fit all when it comes to breast care, and that it’s critical to offer a personalized approach to breast cancer screening,” says Agnes Berzsenyi, President and CEO of Women’s Health at GE Healthcare. “We’re excited to support this important study to further evaluate the clinical benefits of CESM so that clinicians can be even more confident in their diagnosis and quickly get answers for their patients.”

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