None listed
Conditions
Brief summary
This prospective comparative trial embedded in population-based screening, at Maroondah BreastScreen, Eastern Health, will examine screening outcomes of hybrid digital breast tomosynthesis/mammography compared to digital mammography screening (standard of care) in women presenting for routine breast screening. Who is it for? You may be eligible to join this study if you are a woman aged 40 years or above and are attending a BreastScreen service at Maroondah BreastScreen. Study details Current standard of care for breast screening is bilateral two-view (MLO and CC) digital mammography screening which represents 2-dimensional (2D) imaging. Intervention in this study is digital breast tomosynthesis (DBT, quasi-3D-mammography) acquisition for the MLO view only (2D-mammography images will be reconstructed from the DBT to provide synthetic 2D). Standard digital mammography will be acquired for the CC-view. This is referred to as ‘hybrid tomosynthesis/mammography’ screening or the ‘intervention screen’ in this trial. Other aspects of screening and assessment, and any required follow-up, will be based on standard BreastScreen protocols and quality assurance processes. The trial will assess initial detection measures (cancer detection, and recall for further testing) as well as outcomes at follow-up (to determine interval cancer rates).
Interventions
Current standard of care for breast screening is bilateral two-view (MLO and CC) digital mammography screening which represents 2-dimensional (2D) imaging. Intervention: 2D-mammography will be replaced with digital breast tomosynthesis (DBT, quasi-3D-mammography) acquisition for the MLO view only (2D-mammography images will be reconstructed from the DBT to provide synthetic 2D). Standard digital mammography will be acquired for the CC-view. This is referred to as ‘hybrid tomosynthesis/mammography’ screening or the ‘intervention screen’ in this trial. The process for the hybrid (intervention) screen is similar to the routine breast screen in that both involve transient compression of the breasts, x-ray acquisition by a radiographer, and take approximately 15 minutes.
Sponsors
Study design
Eligibility
Inclusion criteria
Women who are eligible to participate in the BreastScreen program and attending for a mammographic screen at Maroondah BreastScreen: East Ringwood screening site (intervention site) and Mont Albert screening site (standard screening site)
Exclusion criteria
- Women aged less than 40 years, or who are (or may be) pregnant or breastfeeding (not eligible for breast screening) -Women deemed unable to provide informed consent (will have standard mammography screen). -Women in whom a ‘pushback’ image cannot be obtained due to their breast implant will be excluded from the hybrid (intervention) screen due to technical issues and will have standard 2D-mammography.