A large study investigating the best modality to screen for breast cancer in asymptomatic women is underway and moving forward at an impressive rate.
As of now the Tomosynthesis Mammographic Imaging Screening Trial (TMIST) has enrolled 16,505 participants across a number of certified mammography clinics in the U.S., Canada and Argentina. The randomized phase 3 trial is comparing standard digital mammography (2D) with the hotly-debated tomosynthesis mammography (3D).
“We have 15 approved clinics working on the logistics to begin enrollment, and another 34 have committed to joining,” the study’s principal investigator Etta Pisano, MD, and chief research officer the American College of Radiology, said in a statement. “We are pleased that there has been a great deal of interest from international sites and expect to bring on additional sites in Europe and Asia in the next 6 months.”
Pisano and co-researchers are following patients set to undergo either 2D or 3D screening exams as part of their routine mammogram for a five-year period. They intend to record whether participants are diagnosed with cancer or a precancerous condition as well as treatment plans and subsequent outcomes. All women range from 45 to 74 years old and will receive screening exams every year or every two years depending on individual risk.
As part of the National Cancer Institute-backed study (part of the National Institutes of Health), researchers are also gathering evidence related to secondary endpoints, including false positives, recall rates, biopsy rates, overdiagnosis, follow-ups and biopsies.
“Any increase in sensitivity with a new technology could be of benefit, harm, or a mixture, but only a randomized trial can sort it out,” said Worta McCaskill-Stevens, MD, MS, director of the NCI Community Oncology Research Program. “The average-risk woman will need personalized guidance about screening tests to make informed decisions around potential risks and benefits in the future.”
The clinical usefulness of digital breast tomosynthesis or 3D mammography has been called into question recently, specifically after an Oct. 21 report from STAT found many monetary ties between manufacturers of the modality and hospitals, lawmakers and physicians.