Development and Clinical Evaluation of Tomosynthesis for Digital Mammography

摘要

Tomosynthesis holds the promise of detecting breast cancer earlier, at a smaller size, with fewer false-positive outcomes. Progress toward this goal has been steady. It has been slowed by the unanticipated need to include an articulating collimator for X-ray beam control. GECRD interpreted recent FDA guidance as requiring the design and installation of an articulating collimator. GECRD has designed and installed this subsystem. The feasibility automatic motorized tomosynthesis system has been delivered, installed and acceptance tested at MGH. A physics report on the imaging characteristics is complete. We are now in position to evaluate tomosynthesis in the clinical setting. This will permit an understanding of it's clinical potential, and if warranted, the design of a clinical trial.