December 01, 2019

ACR, BCRF and GE Healthcare Launch CMIST Trial

Trial to Evaluate Use of Contrast Enhanced Mammography for Screening Women with Dense Breasts

In a new effort to improve early breast cancer detection and reduce false positive exams in women with dense breasts, the American College of Radiology (ACR), Breast Cancer Research Foundation (BCRF) and GE Healthcare are partnering to support the Contrast Enhanced Mammography Imaging Screening Trial (CMIST). 

The planned trial, managed by the ACR Center for Research and Innovation , seeks to determine if 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.

Approximately 40 percent of women age 40 and over have dense breasts, which can make detection of breast cancer more challenging using mammography alone. With wider digital breast tomosynthesis (DBT) adoption, and increased use of supplemental screening ultrasound due to breast density notification laws, many women with dense breasts are screened each year with both DBT and whole breast ultrasound (WBUS).

“CMIST will investigate the challenges of current screening options for women with dense breasts,” said Dorraya El-Ashry, PhD, BCRF Chief Scientific Officer. “The goal is to reduce false positive rates while improving breast cancer detection. Early detection remains key to improving breast cancer outcomes and our collective goal is to optimize critical tools for diagnosis.”

CESM combines mammography and vascular-based screening methods that may offer a more efficient screening approach. CESM 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.1

Expected to launch in spring 2020, the paired-design multicenter trial will evaluate the performance of CESM in screening women with mammographically dense breasts (BI-RADS density categories c and d), ages 40-75, at average-to-intermediate risk for breast cancer, compared to the combination of tomosynthesis and ultrasound. 

“The new CMIST 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.

“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.”

1Sung et al. Radiology Oct 2019

 The CMIST Trial seeks to determine if contrast enhanced spectral mammography (CESM) screening provides more accurate cancer detection than current screening methods in women with dense breasts.

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