News | Mammography | May 05, 2023

Study aims to determine whether CEM improves breast cancer detection for women with dense breasts 

Study aims to determine whether CEM improves breast cancer detection for women with dense breasts

Left: Recombined image of the CEM exam showing iodine uptake, Right: Standard digital mammogram 


May 5, 2023 — The American College of Radiology (ACR), Breast Cancer Research Foundation (BCRF) and GE HealthCare announce the enrollment of the first patients in the Contrast-Enhanced Mammography Imaging Screening Trial (CMIST). This is a significant milestone for the clinical trial that will help determine whether contrast-enhanced mammography (CEM) improves breast cancer detection and reduces false-positive exams in women with dense breasts. 

Breast cancer is currently the most commonly diagnosed cancer among American women – with about one in eight facing a diagnosis in their lifetime.[1] While mammography is considered the standard breast cancer screening tool, its effectiveness is reduced in women with dense breast tissue.[2] 

Dense breast tissue is a lesser-known risk factor that can double one’s risk for breast cancer[3] and will soon require patient notification in the United States as a result of updates to the Mammography Quality Standards Act (MQSA) announced by the U.S. Food and Drug Administration. While dense breast tissue is considered common, with about 40 percent of women aged 40 and older having dense breasts,[4] it can make the detection of breast cancer more challenging. For some patients, tissues can overlap potentially hiding signs of breast cancer; in other cases, the tissue and cancer can show up as white on a mammogram making diagnosis more difficult. As a result, patients often need to seek supplementary screening. 

CEM combines mammography and iodinated contrast media in a simple and quick procedure to highlight areas of unusual blood flow patterns that may indicate malignancy.  The CMIST study seeks to determine if CEM provides more accurate cancer detection compared to digital breast tomosynthesis (DBT), or 3D mammography, in women with dense breasts. As part of CMIST, a total of 2032 women with dense breasts will be enrolled to compare the CEM technique to 3D mammography. 

Carolina Breast Imaging Specialists (CBIS) in Greenville, North Carolina is the first of fifteen planned sites to start recruiting patients, with additional sites across the United States and Canada commencing recruitment in the coming months. The trial is set to deliver the first results in 2025. The trial is registered on ClinicalTrials.gov under NCT05625659

“We are very proud and excited to have enrolled the first patients in the multi-center CMIST trial,” said Dr. Bruce Schroeder – Medical Director and CEO of Carolina Breast Imaging Specialists. “Our patients have been eager to participate in this landmark trial both for its potential to find the earliest cancers and for its role in providing much needed data to our global knowledge base.  We expect this long-awaited study to show us the value of finally having a highly effective, low-cost examination for women with dense breasts and other challenging circumstances.” 


“I am extremely excited about this landmark clinical trial,” said Christopher Comstock, MD, FACR, FSBI, CMIST Study Chair. “Despite incremental improvements in mammographic technique over the past 50 years, screening mammography may still not detect many lethal breast cancers, especially in women with dense breasts. This trial will help us to determine whether CEM can find many cancers that would otherwise be missed on screening mammography and help to usher in a new screening paradigm.” 

“Dense breast tissue is not only a risk factor, but also makes it increasingly difficult to identify breast cancer. The FDA’s recent announcement requiring a single national “dense breast” reporting standard after years of advocacy is a win for patients, as well as providers, in the fight against breast cancer,” said Jyoti Gupta, PhD – President & CEO for Women’s Health and X-ray at GE HealthCare. “Providing women with this information offers the potential for early diagnosis and empowers women with dense breasts to make informed and personalized decisions about their breast health through supplemental imaging, like contrast-enhanced mammography. I’m excited to see our Senographe Pristina mammography system, SenoBright HD CEM technology and contrast media from our Pharmaceutical Diagnostics segment being used to further evaluate the clinical benefits of CEM as part of our efforts to improve breast cancer outcomes.” 

For more information: www.acr.org 

 

References: 


1] Breastcancer.org. Breast Cancer Facts and Statistics. Available at: https://www.breastcancer.org/facts-statistics. Last accessed March 2023.  


[2] Buchberger W, Geiger-Gritsch S, Knapp R, Gautsch K, Oberaigner W. Combined screening with mammography and ultrasound in a population-based screening program. Eur J Radiol. 2018 Apr;101:24-29  


[3] Nelson HD, Zakher B, Cantor A, et al. Risk factors for breast cancer for women aged 40 to 49 years: a systematic review and meta-analysis. Ann Intern Med. 2012;156(9):635-648. 


[4] Pisano et al. NEJM 2005; 353: 1773. 

 

Related CMIST Content: 


One on One … with Wendie Berg, MD, PhD, FACR, FSBI 


How New Mammography Enhancements Benefit Both Women and Providers 


AI Software Firm Announces Support of DenseBreast-info.org Ahead of SBI 2023 Symposium 


Projection Order, Acquisition Timing for Contrast-Enhanced Mammography 


Deep Learning Model Estimates Cancer Risk from Breast Density 


VIDEO: FDA Update on the US National Density Reporting Standard - A Discussion on the Final Rule 


Related Content

News | Breast Density

May 25, 2023 — Researchers from the Mayo Clinic (Rochester, MN) and University of California, San Francisco confirmed ...

Time May 25, 2023
arrow
News | Breast Imaging

May 25, 2023 — GE HealthCare, a leader in breast cancer care technology and diagnostics, has today announced that NCCN ...

Time May 25, 2023
arrow
News | Ultrasound Women's Health

May 25, 2023 — According to an accepted manuscript published in ARRS’ own American Journal of Roentgenology (AJR), deep ...

Time May 25, 2023
arrow
News | Artificial Intelligence

May 24, 2023 — Since the launch of ChatGPT in November 2022, the use of large language models (LLMs) powered by ...

Time May 24, 2023
arrow
News | Radiation Oncology

May 22, 2023 — Physicians and scientists from the UCLA Jonsson Comprehensive Cancer Center will discuss the latest ...

Time May 22, 2023
arrow
News | Mammography

May 22, 2023 — Incorrect advice by an AI-based decision support system could seriously impair the performance of ...

Time May 22, 2023
arrow
News | ACR

May 19, 2023 — The Radiology Leadership Institute (RLI) named Norman J. Beauchamp Jr., MD, MHS, FACR, Arl Van Moore Jr ...

Time May 19, 2023
arrow
News | Contrast Media

May 16, 2023 — Bracco Imaging, an innovative world leader delivering end-to-end products and solutions through a ...

Time May 16, 2023
arrow
News | Breast Imaging

May 16, 2023 — DenseBreast-info.org has issued a statement which states that the USPSTF Guideline should not apply to ...

Time May 16, 2023
arrow
News | Breast Imaging

May 15, 2023 — RSNA updated its Statement on Screening for Breast Cancer, recognizing new recommendations from the ...

Time May 15, 2023
arrow
Subscribe Now