High-resolution, quantitative whole-breast ultrasound: bridging the gap to clinical practice

DESCRIPTION provided by applicant The SoftVue ultrasound tomography UST system provides a solution for imaging the whole breast by combining volumetric imaging capability with cost efficacy absence of ionizing radiation and operator independence Our long term goal is to develop imaging system that rivals the imaging performance of MRI in order to provide a low cost alternative to MRI and an expanded role in breast screening In Phase I we demonstrated based on numerical models that waveform tomography can achieve MRI like images in terms of resolution and can be implemented on clinically relevant time scales In subsequent preliminary studies we have applied waveform tomography to in vivo data The objective of this Phase II study is to refine waveform tomography and integrate it into a clinical software package that would be ready for productization in support of our commercialization plan Our central hypothesis is that the integrated waveform tomography will be able to produce in vivo breast images with MRI like quality on clinically relevant time scales The hypothesis will be tested via a study of patients who have been identified by standard of care to have suspicious lesions and also have MR images available for comparison The expected outcome is a clinical validation of the proposed technique which in turn will support SoftVueandapos s role as a diagnostic modality for breast imaging in the short term and as a screening modality in the long term The rationale for this study is that it will advance SoftVue to achieve our goal of eliminating the dilemma between imaging cost and imaging performance and support commercialization of the SoftVue system Our proposed study will be carried out via the following specific aims Aim Assess the performance of the proposed technique on data acquired with the SoftVue system Aim Implement design of the new SoftVue blade server from the Phase I study to reflect state of the art architecture for both CPUs and GPUs and thereby maximize the computational capacity Aim Implement and test the proposed algorithm on the new SoftVue blade server architecture using in vivo data and assess the computational speed for clinical applications Aim Package the algorithm with the SoftVue product and support SoftVueandapos s FDA applications PUBLIC HEALTH RELEVANCE The proposed research assesses the performance of the optimized waveform ultrasound tomography integrated with the commercial grade SoftVue system for in vivo breast imaging Successful outcome of the proposed technique will support SoftVueandapos s role as a diagnostic modality for breast imaging in the short term and as a screening modality in the long term