This post was contributed by Etta Pisano, MD, principal investigator for the TMIST Trial, chief science officer of the ACR Center for Research and Innovation, and professor of radiology at Beth Israel Deaconess Medical Center/Harvard Medical School.
The Tomosynthesis Mammographic Imaging Screening Trial (TMIST) is up and running with 37 sites now open for accrual. An additional 93 sites will open over the next several months.
In fact, more than 4,100 women are enrolled to date, including 3,000 in a preliminary protocol at four Canadian sites. TMIST will ultimately enroll 164,946 women across approximately 130 sites over the next 3–4 years.
The trial will determine whether screening with tomosynthesis (TM) reduces the number of potentially life-threatening cancers in women compared with digital mammography (DM) detected over a 4.5-year period.
TMIST will randomize asymptomatic women ages 45–74 who present for breast cancer screening at participating clinics to either TM or DM. These women will be screened annually or biennially based on specific breast cancer risk factors during the first five years of participation. They will then be followed through a combination of chart review and patient interview for up to an additional three years.
Secondary aims will compare the two modalities regarding health care utilization, recall rates, biopsy rates, diagnostic accuracy, interval cancer rates, and pathologic and genetic (PAM50) analysis, with correlation to imaging findings. Blood and buccal smears will be collected from consenting participants to allow for biomarker discovery.
The study is open to institutions with membership in any of the National Cancer Institute (NCI) adult National Clinical Trials Research Bases across the United States — ECOG-ACRIN, Alliance, NRG, SWOG and NCORP. The study is also open to institutions in Canada through the Canadian Clinical Trials Group membership.
A mixture of academic centers, private imaging centers and community based hospital practices are participating in the trial. TMIST is a federally funded study sponsored by the NCI Division of Cancer Control and Prevention and is being led by the ECOG-ACRIN Research Base.
- Is your institution participating in TMIST?
- What’s been your experience with digital mammography and/or tomosynthesis?
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