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Laser Optoacoustic Ultrasonic Imaging System Assembly (LOUISA-3D) was developed in response to demand of diagnostic radiologists for an advanced screening system for the breast to improve on low sensitivity of x-ray based modalities of mammography and tomosynthesis in the dense and heterogeneous breast and low specificity magnetic resonance imaging. It is our working hypothesis that co-registration of quantitatively accurate functional images of the breast vasculature and microvasculature, and anatomical images of breast morphological structures will provide a clinically viable solution for the breast cancer care. Functional imaging is LOUISA-3D is enabled by the full view 3D optoacoustic images acquired at two rapidly toggling laser wavelengths in the near-infrared spectral range. 3D images of the breast anatomical background is enabled in LOUISA-3D by a sequence of B-mode ultrasound slices acquired with a transducer array rotating around the breast. This creates the possibility to visualize distributions of the total hemoglobin and blood oxygen saturation within specific morphological structures such as tumor angiogenesis microvasculature and larger vasculature in proximity of the tumor. The system has four major components: (i) a pulsed dual wavelength laser with fiberoptic light delivery system, (ii) an imaging module with two arc shaped probes (optoacoustic and ultrasonic) placed in a transparent bowl that rotates around the breast, (iii) a multichannel electronic system with analog preamplifiers and digital data acquisition boards, and (iv) computer for the system control, data processing and image reconstruction. The most important advancement of this latest system design compared with previously reported systems is the full breast illumination accomplished for each rotational step of the optoacoustic transducer array using fiberoptic illuminator rotating around the breast independently from rotation of the detector probe. We report here a pilot case studies on one healthy volunteer and on patient with a suspicious small lesion in the breast. LOUISA3D visualized deoxygenated veins and oxygenated arteries of a healthy volunteer, indicative of its capability to visualize hypoxic microvasculature in cancerous tumors. A small lesion detected on optoacoustic image of a patient was not visible on ultrasound, potentially indicating high system sensitivity of the optoacoustic subsystem to small but aggressively growing cancerous lesions with high density angiogenesis microvasculature. The main breast vasculature (0.5-1 mm) was visible at depth of up to 40-mm with 0.3-mm resolution. The results of LOUISA-3D pilot clinical validation demonstrated the system readiness for statistically significant clinical feasibility study.
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