The long-term objectives of this project are to develop a high-performance, cost-effective clinical prototype of a unique breast imaging system, HABIS, that uses non-ionizing ultrasound for examination of the breast and to demonstrate the medical value and clinical efficacy of the system through trials of the system in medical-center and outpatient imaging-center settings. The immediate objectives in Phase I of this SBIR application are to confirm that HABIS meets acoustic and electrical safety requirements as well as expectations for resolution, and to accumulate a portfolio of initial human subject images that will aid the planning of more extensive human trials in a later SBIR Phase-II project. The imaging system is designed to overcome x-ray mammography limitations of poor resolution of contrast in dense breasts (i.e., breasts with high x-ray attenuation), discomfort and anatomical deformation induced by compression, and poor imaging of breasts with implants. The system consists of a custom data-acquisition apparatus, a high-performance computer network, and novel software that controls the collection of data and forms volumetric images having isotropic high resolution (100 µm). These images are reconstructions of sound speed and attenuation slope based on inverse scattering as well as aberration-corrected b-scans. Unique features of the system are: collection of scattering data from the entire breast volume in about two seconds without any moving parts to minimize image degradation from motion, extrapolation of measured scattering to obtain virtual measurements in the opposite hemisphere where actual measurements are impossible to obtain directly, and simultaneous independent reconstruction of subvolumes to speed the reconstruction process. Phase I has four specific aims: 1) Conduct acoustic and electrical tests to confirm that HABIS is safe for patient use and secure approval for human imaging studies. 2) Quantify HABIS point and contrast resolution and confirm that resolution meets calculated expectations by using images of contrast and resolution phantoms. 3) Develop image acquisition and review protocols suitable for use by technicians and clinicians, and optimize imaging algorithms to ensure efficient validation of data acquisition and clinical review of quantitative and b-scan images. 4) Assemble a portfolio of HABIS images acquired from 10-20 human subjects with normal as well as abnormal mammographic results that will be used to guide the development of a plan for extensive human trials in an SBIR Phase-II project. The major results of the Phase-I aims would be proof that HABIS complies with standards for patient safety, approval for human studies by an institutional review board, quantified point and contrast resolution of HABIS, optimized HABIS software suitable for patient imaging to be conducted by clinical collaborators, and human subject images that will provide preliminary evidence of the medical value of HABIS and indicate questions to be addressed in SBIR Phase-II human trials. Achievement of the long-term goals of this project would lay the foundation for additional studies that could change the present clinical paradigm of imaging for breast-cancer detection, diagnosis, and monitoring of response to treatment.
Public Health Relevance Statement: Public Health Relevance: HABIS, a novel breast imaging system that uses a hemispheric ultrasound transducer array, was developed as a research instrument by the Investigators. The system uses more than 10,000 transducer elements with independent and parallel acquisition channels to collect a complete set of pulse-echo measurements of the breast in about two seconds without the need for mechanical translation of the transducers. The measurements are rendered into volumetric b-scan and quantitative images of the breast by a dedicated, custom network of high-performance computing nodes that perform, on site, the massively parallel computations needed for timely reconstructions. These innovations allow breast imaging of unprecedented resolution with greatly reduced motion artifacts. Extensive commercial activity in the area of breast imaging in general, and ultrasound breast imaging in particular, provides evidence of ample market opportunities for novel and superior imaging modalities. Numerical simulations already support the theoretical medical advantages of HABIS. The long-term purpose of the proposed SBIR project is to provide clinical evidence of these theoretical advantages using extensive in vivo human imaging studies and to transform the research instrument into a commercially viable clinical imaging system. The immediate objectives of the Phase-I project are to confirm that HABIS meets patient safety requirements and expectations for resolution, and to accumulate a portfolio of initial human images that will aid the design of more extensive human trials in a later SBIR Phase-II project. Successful completion of the overall project could significantly advance the state of breast-cancer detection, diagnosis, and monitoring response to treatment.
NIH Spending Category: Bioengineering; Breast Cancer; Cancer; Clinical Research; Diagnostic Radiology; Networking and Information Technology R&D; Patient Safety; Prevention
Project Terms: Achievement; Acoustics; Address; Algorithms; Architecture; Area; attenuation; base; Breast; Breast Cancer Detection; breast imaging; Caring; Clinical; clinical efficacy; Collection; Color; computer network; Computer software; contrast imaging; cost effective; Custom; Data; data acquisition; Data Collection; design; Development; Diagnosis; Elements; Energy Transfer; Ensure; expectation; experience; Extravasation; Foundations; Goals; high end computer; High Performance Computing; Hour; Housing; Human; human study; human subject; Image; Image Reconstructions; imaging modality; imaging software; imaging system; Imaging Techniques; Implant; in vivo; indexing; innovation; Institutional Review Boards; instrument; Magnetic Resonance Imaging; malignant breast neoplasm; Malignant Neoplasms; Mammography; Marketing; Measurement; Measures; Mechanics; Medical; Medical center; meetings; Monitor; Morphologic artifacts; Morphology; Motion; novel; Outpatients; parallel computer; patient privacy; patient safety; Patients; Performance; Phase; Physiologic pulse; Policies; Process; Protocols documentation; prototype; public health relevance; quantitative imaging; reconstruction; Reporting; Research; Research Personnel; Research Subjects; Resolution; response; Safety; safety testing; Scanning; Secure; simulation; Site; Small Business Innovation Research Grant; sound; Speed (motion); System; Testing; Time; Touch sensation; Transducers; Translations; Ultrasonic Transducer; Ultrasonography; Universities; Validation; virtual; Woman
