October 16, 2019
The Tomosynthesis Mammographic Imaging Screening Trial (TMIST) is now open to accrual. The primary endpoint of the study is to 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. The study will randomize asymptomatic women who present for breast cancer screening at participating clinics and who are between the ages of 45 and 74 to either TM or DM. Enrolled women will undergo screening with TM or DM annually or biennially based on specific breast cancer risk factors during first 5 years of participation and then will be followed through combination of chart review and patient interview for up to an additional 3 years. Secondary aims will compare the two imaging modalities in terms of health care utilization, recall rates, biopsy rates, diagnostic accuracy, interval cancer rates, and pathologic and genetic (PAM50) analysis, with correlation to imaging findings. Importantly, blood and buccal smears will be collected from consenting participants to allow for biomarker discovery. Quality Assurance of the mammography units included in the trial will be carefully monitored through the TMIST Physics QC Program.
The study will enroll 164,946 women across approximately 130 sites.
The study rationale, aims and methods will be discussed.
Dr. Etta Pisano is Professor in Residence of Radiology at Harvard Medical School and Chief Research Officer at the American College of Radiology. She is also currently serving as the Study Chair for the Tomosynthesis Mammographic Imaging Screening Trial, a National Cancer Institute-funded clinical trial under the auspices of the ECOG-ACRIN research base, which will enroll over 165,000 women in 150 sites in the US and Canada.
Prior to her current roles, she served at the Medical University of South Carolina (MUSC) as Vice President for Medical Affairs and Dean of the College of Medicine and as Vice Dean for Academic Affairs at the University of North Carolina (UNC) School of Medicine, Kenan Professor of Radiology and Biomedical Engineering, Director of the UNC Biomedical Research Imaging Center, and Director of the N.C. Translational and Clinical Sciences Institute. She is an expert in breast cancer imaging and, for almost 16 years, she served as the Chief of Breast Imaging at UNC Hospitals. Her undergraduate degree in Philosophy is from Dartmouth College and her medical degree is from Duke University. Etta’s professional interests center around the development, application and testing of imaging technology for the early detection and diagnosis of breast cancer and other breast problems.
Etta was born in New York City and was raised in the suburbs of Philadelphia. After completing a rotating internship in a community-based program in Pensacola, Florida, she completed her radiology residency at Beth Israel Hospital of Harvard Medical School. After her residency, she spent a year as Chief of Breast Imaging and Instructor in Radiology at the same institution. She is a Past President of the Association of University Radiologists and the American Association for Women Radiologists. Etta served as the Principal Investigator of the largest clinical trial ever run by a radiologist, the Digital Mammographic Imaging Screening Trial (DMIST), which enrolled 49,528 women in a study comparing digital to film mammography, the results of which were published in 2005 in the New England Journal of Medicine. In 2003, she was appointed the first Director of the UNC Biomedical Research Imaging Center, a core facility that develops and commercializes new imaging technologies.
In 2008 Etta was elected as a member of the Institute of Medicine of the National Academy of Sciences. She is a recipient of the Gold Medal from the Association of University Radiologists (2010), the American Roentgen Ray Society (2012), and the Radiologic Society of North America (2014) and of the Alice Ettinger Distinguished Achievement Award from the American Association for Women Radiologists (2012). At MUSC and UNC, Etta received honors for her work on behalf of faculty diversity. Etta received the National Women’s History Museum Helen Taussig Living Legacy Award in 2013.