TMIST breast cancer screening trial enrollment surpasses 100,000

The Tomosynthesis Mammographic Imaging Screening Trial (TMIST) has now enrolled more than 100,000 women in the United States and abroad. One of the fastest-growing National Cancer Institute (NCI)-sponsored trials, TMIST has expanded to 134 participating clinical sites in the US, Argentina, Canada, Peru, Italy, South Korea, and now Thailand. Study leaders are accepting new imaging sites until July 1, 2024.  

“Breast cancer screening levels remain below pre-COVID-19 pandemic levels. Yet, TMIST enrollment continues to grow and has doubled since the start of the pandemic,” said TMIST Study Chair Etta D. Pisano, MD. “As we accelerate toward full target enrollment, we urge all imaging facilities with breast tomosynthesis and digital mammography to join this trial and be part of its success.” 

TMIST is the first randomized, controlled trial designed to identify women in whom digital breast tomosynthesis (DBT) may outperform two-dimensional (2-D) digital mammography in reducing advanced breast cancer development. Although tomosynthesis, also called three-dimensional (3-D) mammography, is a newer technology, investigators want to evaluate its ability to find more of the aggressive types of cancers likely to kill women by comparing it to standard digital mammography.  

The study is also creating the world’s largest curated dataset of breast cancer screening clinical data, images, and biospecimen samples. The data collected through TMIST will lead to better, individualized screening strategies based on each woman’s risk factors. Some women may benefit from less screening, while others may require more intensive screening. 

“Wouldn’t it be better if we could adapt based on new knowledge and provide individualized recommendations? We could develop a tool that allows us to tell individual women, ‘Given your risk factors, your particular circumstances, and your genetics, here is what we recommend’.” Said Dr. Pisano. 

The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) is leading TMIST with funding from the NCI, part of the National Institutes of Health. With NCI support, ECOG-ACRIN is also overseeing outreach efforts to recruit a diverse mix of sites and participants. The American College of Radiology Center for Research and Innovation™ manages trial implementation at TMIST sites, including site readiness and support for trial accrual, data collection, and management, as well as image collection and management. 

“TMIST payment for each patient enrolled and each screening exam performed, coverage for women who qualify for charity care, and the ability for institutions to apply for a funding advance to help hire a TMIST-dedicated research coordinator all make TMIST an ideal trial to take part in,” said ECOG-ACRIN Group Co-Chair Mitchell D. Schnall, MD, PhD. 

Less than half of all accredited mammography scanners are DBT units, and 11% of US imaging facilities do not have a DBT scanner. Many of these sites may be in underserved areas. A Journal of the American College of Radiology (JACR®) study showed that Black women are far less likely to be screened with DBT than white or Asian women.  

TMIST funding provides payment for mammography screening for participants who qualify for charity care at their participating site. The trial may be the only way for women in underserved and rural areas to access routine screening.  

“While TMIST trial participation continues to steadily grow, we need more sites to participate, particularly those in underserved areas,” said Dr. Pisano. 

TMIST is recruiting one of the most racially diverse populations of any NCI trial. The study provides education and recruitment materials in multiple languages—including Chinese, English, Korean, Spanish, and Vietnamese. Nearly 21% of US women in the study are Black or African American, more than twice the average Black cohort in NCI clinical trials of 9%. A wide variety of promotional and educational resources are available to assist trial sites with recruitment. Several national organizations promote and support the study, including the National Medical Association, Susan G. Komen, and others.  

“The momentum of TMIST is clear, and its expanding enrollment speaks to the significance of the study question—which remains unanswered—as well as the success of sites effectively reaching women in their communities,” said ECOG-ACRIN Group Co-Chair Peter J. O’Dwyer, MD. “TMIST is gathering a study population able to provide much-needed data to move breast cancer screening and health equity forward.” 

Interested sites may visit acr.org/TMIST, read this card, and watch this video. Interested site personnel may contact TMIST staff to discuss the study requirements, reimbursement/payment structure, and the application process. 

About ECOG-ACRIN 

The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) is an expansive membership-based scientific organization that designs and conducts cancer research involving adults who have or are at risk of developing cancer. The Group comprises nearly 1400 member institutions and 21,000 research professionals in the United States and around the world. ECOG-ACRIN is known for advancing precision medicine and biomarker research through its leadership of major national clinical trials integrating cutting-edge genomic approaches. Member researchers and advocates collaborate across more than 40 scientific committees to design studies spanning the cancer care spectrum, from early detection to management of advanced disease. ECOG-ACRIN is funded primarily by the National Cancer Institute, part of the National Institutes of Health. Follow us on Twitter/ X @eaonc, Facebook, LinkedIn, Instagram, and YouTube, or call 215.789.3631.