Iron overload affects life of many people in the US and around the world. Liver iron concentration provides a direct indicator of body iron level. Among various noninvasive methods, Biomagnetic liver susceptometry (BLS) has been proven to provide the only direct means of determining hepatic iron stores. However, BLS requires cost-prohibitive (~ 1 million) and complex (~ 4 K, liquid helium) SQUID magnetometer, which limits the clinical adoption of this technology. The objective of this SBIR project is to develop a low-cost, compact-size, and portable room temperature biomagnetic liver susceptometry (PM BLS) based on piezoelectric biomagnetic sensor for general clinical use to quickly, easily, noninvasively, and quantitatively assess liver iron concentration. The proposed effort explores the unique opportunity afforded by recent advances in piezo-magnetic sensors that exhibit ultra-high AC magnetic sensitivity in the presence of strong DC magnetic background and breakthrough at Prof. Zhangs laboratory of Penn State University (PSU) in successful demonstration of the performance of piezo-magnetic sensor using liver phantoms. Specifically, Nascent Devices LLC proposes to develop a piezoelectric magnetic (PM) sensor susceptometer and carry out a direct comparison with the SQUID BLS at UCSF Benioff Childrens Hospital Oakland, CA. In Aim 1, we will develop a compact PM sensor susceptometry, a first order gradiometer configuration and ready for clinical study. In Aim 2, we will carry out calibration of the PM sensors with Liver phantoms of different iron concentrations and compared with computer simulation results. In Aim 3, direct comparison of the first order PM biomagnetic susceptometry with the SQUID BLS on human subjects. Available test results reveal that our PM BLS will have equal or better sensitivity to SQUID BLS in assessing liver iron concentration (LIC) due to closer distance to the liver, improved SNR at higher scan rate, and greater flexibility and mobility with much lower cost (
Public Health Relevance Statement: Development of a low cost and portable biomagnetic liver susceptometry (BLS) will greatly improve the clinical practice in managing the diseases associated with iron overload. To reach this goal, we propose to develop BLS based on piezoelectric biomagnetic sensor for general clinical use to quickly, easily, noninvasively, and quantitatively assess liver iron concentration. The proposed development effort explores the unique opportunity afforded by recent advances in piezo-magnetic sensors that exhibit ultra-high AC magnetic sensitivity in the presence of strong DC magnetic background.
Project Terms: Adopted; Adoption; Affect; base; Beds; Blood Tests; Calibration; Centers for Disease Control and Prevention (U.S.); Clinic; Clinical; Clinical Management; clinical practice; Clinical Research; Complex; computer code; Computer Simulation; cost; Country; Data; design; Development; Devices; Disease; disorder prevention; Dose; Early Diagnosis; Electronics; Engineering; Exhibits; Ferritin; flexibility; Future; Goals; Helium; Hepatic; Hereditary hemochromatosis; Human body; human subject; improved; Infection; Institutional Review Boards; Iron; Iron Overload; Laboratories; Lead; Life; Liquid substance; Liver; Location; Magnetic Resonance Imaging; Magnetism; Measurement; Measures; Methods; Noise; Organ; Patients; Pediatric Hospitals; Performance; Phase; Physicians; Play; Predisposition; programs; Role; Scanning; sensor; Serum; Side; Signal Transduction; simulation; Small Business Innovation Research Grant; Staging; superconducting quantum interference device; System; Technology; Temperature; Test Result; Testing; Tissues; Translations; Ultrasonography; Universities; Work
