TMIST Passes 80000 Patients Enrolled

Tomosynthesis Mammographic Imaging Screening Trial (TMIST) enrollment has soared past 80,000. Even as screening mammography volumes remain below pre-pandemic levels, 124 active sites continue to enroll women at a pace nearly unheard of in the COVID era.

TMIST sites are also assembling one of the most diverse cancer screening trial populations. Black participation stands at 21 percent — more than double the average Black participation rate in National Cancer Institute-funded clinical trials (9%).

TMIST is also creating one the world’s largest curated datasets of breast cancer screening clinical data, images and bio-specimens to help researchers tailor future screening to a woman’s individual risk. Approximately 70% of TMIST participants have volunteered to submit blood and/or buccal smears to this new biorepository. These samples will be used to link genetic data from TMIST participants with other information in developing individualized breast cancer screening strategies.

Study Chair Etta Pisano, MD, FACR, continues to schedule meetings with physicians from prospective sites in underserved communities. Pisano and ECOG-ACRIN Health Equity Committee Co-Chair Edith Mitchell MD, say the successes to date are no accident, but the result of personalized recruiting of women by staff at local facilities and a forward-thinking study design that includes:

• TMIST coverage for exams for many uninsured or under-insured women.
• Funding to sites for special initiatives to enhance representation of underrepresented populations.
• Additional financial support for sites demonstrating high accrual to sustain that volume over time.
• National association and local provider efforts to reconnect with women for breast cancer screening.
• Advanced payment to qualifying sites to fund dedicated research staff as they begin TMIST participation.

TMIST wants to add sites that serve Native American and Asian communities in the northern Rocky Mountain and Northern Plains regions — including Montana, Wyoming, North Dakota and South Dakota — as well as Oklahoma, Kansas and Missouri. The study also continues to seek out sites serving large Hispanic communities. To help recruit these women, recruitment and patient materials are available in English, Spanish, Chinese Simplified, Korean and Vietnamese. Reaching women of many races in their communities can ensure trial results can be broadly applied and advance health equity.

Only 46% of accredited mammography scanners are Digital Breast Tomosynthesis (DBT) units, and 15% of U.S. imaging facilities do not have DBT scanners. Many of these sites may be in underserved areas. A Journal of the American College of Radiology (JACR®) study shows Black women are less likely to be screened with DBT than white or Asian women.

TMIST is the first randomized, controlled trial to identify women in which DBT may outperform two-dimensional (2D) digital mammography in reducing advanced breast cancer development.

Sites interested in joining TMIST are invited to 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 application process.

Existing and prospective sites can also consider the supplemental trial EAQ201 assessing COVID-19-related financial hardship and distress in women who decline participation in TMIST.