In cone-beam breast CT, scattered photons form a large portion of the acquired signal, adversely impacting image quality throughout the frequency response of the imaging system. Prior simulation studies provided proof of concept for utilization of a hardware solution to prevent scatter acquisition. Here, we report the design, implementation, and characterization of an auxiliary apparatus of fluence modulation and scatter shielding that does indeed lead to projections with a reduced level of scatter. An apparatus was designed for permanent installation within an existing cone-beam CT system. The apparatus is composed of two primary assemblies: a "Fluence Modulator" (FM) and a "Scatter Shield" (SS). The design of the assemblies enables them to operate in synchrony during image acquisition, converting the sourced x-rays into a moving narrow beam. During a projection, this narrow beam sweeps the entire fan angle coverage of the imaging system. As the two assemblies are contingent on one another, their joint implementation is described in the singular as apparatus FM-SS. The FM and the SS assemblies are each comprised a metal housing, a sensory system, and a robotic system. A controller unit handles their relative movements. A series of comparative studies were conducted to evaluate the performance of a cone-beam CT system in two "modes" of operation: with and without FM-SS installed, and to compare the results of physical implementation with those previously simulated. The dynamic range requirements of the utilized detector in the cone-beam CT imaging system were first characterized, independent of the mode of operation. We then characterized and compared the spatial resolution of the imaging system with, and without, FM-SS. A physical breast phantom, representative of an average size breast, was developed and imaged. Actual differences in signal level obtained with, versus without, FM-SS were then compared to the expected level gains based on previously reported simulations. Following these initial assessments, the scatter acquisition in each projection in both modes of operation was investigated. Finally, as an initial study of the impact of FM-SS on radiation dose in an average size breast, a series of Monte Carlo simulations were coupled with physical measurements of air kerma, with and without FM-SS. With implementation of FM-SS, the detector's required dynamic range was reduced by a factor of 5.5. Substantial reduction in the acquisition of the scattered rays, by a factor of 5.1 was achieved. With the implementation of FM-SS, deposited dose was reduced by 27% in the studied breast. The disclosed implementation of FM-SS, within a cone-beam breast CT system, results in reduction of scatter-components in acquired projections, reduction of dose deposit to the breast, and relaxation of requirements for the detector's dynamic range. Controlling or correcting for patient motion occurring during image acquisition remains an open problem to be solved prior to practical clinical usage of FM-SS cone-beam breast CT.
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