Personalized recruiting of women by staff at local facilities and a forward-thinking study design set TMIST apart

The study chair for this trial is Etta Pisano, MD (University of Pennsylvania/American College of Radiology).

Tomosynthesis Mammographic Imaging Screening Trial (TMIST) enrollment stands at 81,616 women as of January 27, 2023. Even as screening mammography volumes remain below pre-pandemic levels, 124 active TMIST 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. For example, Black participation stands at 21% — more than double the average Black participation rate in National Cancer Institute-funded clinical trials (9%).

TMIST is also creating one of the world’s largest curated datasets of breast cancer screening clinical data, images, and biospecimens 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.

Dr. Pisano continues to schedule meetings with physicians from prospective sites in underserved communities. She and ECOG-ACRIN Health Equity Committee Co-Chair Edith P. Mitchell, MD (Sidney Kimmel Cancer Center at Thomas Jefferson University), say the successes to date are no accident. Instead, they are 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 the 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.

Current Recruitment Targets

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.

Why TMIST?

Only 46% of accredited mammography scanners are three-dimensional (3-D) units, also called digital breast tomosynthesis (DBT) units, and 15% of US imaging facilities do not have 3-D 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 (2-D) digital mammography in reducing advanced breast cancer development.

New Sites May Join

Dr. Pisano invites sites interested in joining TMIST 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.

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A similar article originally appeared in the January 7, 2023 issue of the American College of Radiology’s Advocacy in Action eNews.