SBIR-STTR Award

?There is a clinical need for new neurovascular imaging techniques for the diagnosis, staging, and monitoring of acute stroke and sub-acute stenoses, arterial-venous malformations (AVMs), and aneurysms, among others. Together, these etiologies frequently manifest in acute stroke and kill over 130,000 people per year with an estimated cost the US healthcare system of over 36.5 billion dollars per year. A reliable and non-invasive neurovascular stress test, similar in concept to a cardiac stress test, would revolutionize cerebrovascular imaging and stroke prevention. It is well known that perfusion imaging, combined with a means of altering cerebral perfusion pressure or cerebrovascular resistance, can measure a patient's cerebrovascular reserve and predict the risk of stroke. Current neurovascular imaging techniques suffer from limitations in radiation exposure, safety, speed, sensitivity, and specificity that prevent their use in measuring cerebrovascular reserve. Magnetic particle imaging (MPI) is a new imaging technology that answers a clinical need for a safe, rapid 3D perfusion and 3D angiography technique without ionizing radiation or toxic tracers to image intracranial diseases such as stenosis (stroke), aneurysm, vasospasms and malformations. The MPI tracer is made with Iron Oxide (SPIO), significantly safer than Iodine (used in CT and fluoroscopy), and Gadolinum (used in MRI). The safe tracer and absence of harmful radiation leads to reduced long term medical costs for patient undergoing diagnostic angiography, and especially patients undergoing repeated diagnostic angiography procedures associated with long term care. MPI produces absolutely no signal from overlying tissues creating a positive contrast and quantitative angiography images or real time perfusion with unprecedented contrast to- noise and signal-to-noise. Successful completion of a human brain imager will mark the beginning of a new field of diagnostic imaging comparable in scope to the introduction of MRI, CT, or Ultrasound. This project aims to develop the first high resolution real time MPI system tailored for clinical cerebrovascular imaging. The proposed system will be the world's highest sensitivity and highest resolution tomographic MPI scanner. In Phase I of this SBIR, we will complete the main magnet design, build a 1/4 scale prototype, and develop our manufacturing plan. In Phase II we will construct the magnet and obtain phantom and animal images. In Phase III we will perform animal and then human testing

Public Health Relevance Statement:


Public Health Relevance:
Magnetic Particle Imaging (MPI) is a new imaging modality whose unique contrast, safety, and speed solves several limitations and concerns of current neurovascular imaging protocols. Mutagenic radiation, kidney disease and brain damage has caused major concern and re-evaluation on the use of CT angiography and MR angiography methods. Here we propose to commercialize the first cerebrovascular MPI imager offering an alternative and new modality to allow safe assessment, staging and monitoring of neurovascular diseases such as stroke, aneurism and other vaso-malformations. Successful completion of a human brain MPI imager will mark the beginning of a new field of diagnostic imaging comparable in scope to the introduction of MRI, CT, or Ultrasound.

NIH Spending Category:
Bioengineering; Brain Disorders; Diagnostic Radiology; Drug Abuse (NIDA only); Neurosciences; Stroke; Substance Abuse

Project Terms:
Acute; acute stroke; Amplifiers; Aneurysm; Angiography; animal imaging; Animals; Biological Sciences; Biomedical Engineering; Blood Vessels; Brain; Brain Injuries; Businesses; Caliber; Cardiovascular system; Centers for Disease Control and Prevention (U.S.); Cerebral perfusion pressure; cerebrovascular; cerebrovascular imaging; Clinical; computer science; Computer software; Contracts; contrast imaging; cost; design; design and construction; Development; Diagnosis; Diagnostic; Diagnostic Imaging; Discipline of Nuclear Medicine; Disease; Electrical Engineering; Electronics; Engineering; Equipment; Etiology; Evaluation; Fluoroscopy; Frequencies (time pattern); Future; Goals; Grant; Health; Healthcare Systems; Human; Image; imaging modality; imaging system; Imaging Techniques; Imaging technology; Industry; innovation; Iodine; Ionizing radiation; Iron; iron oxide; Kidney Diseases; Killings; Lead; Long-Term Care; magnetic field; Magnetic Resonance Imaging; Magnetism; malformation; Malignant Neoplasms; Measures; Mechanics; Mediation; Medical; member; Methods; millimeter; Modality; Modeling; Monitor; nanoparticle; new technology; Noise; Organ; particle; Patients; Perfusion; Phase; pre-clinical; prevent; Procedures; professor; programs; Protocols documentation; prototype; Radiation; reconstruction; Resistance; Resolution; response; Risk; Rotation; Safety; Sensitivity and Specificity; Signal Transduction; Small Business Innovation Research Grant; Speed (motion); Staging; Stenosis; Stress Tests; stroke; Stroke prevention; Structure; System; Techniques; Technology; Testing; Thallium Myocardial Perfusion Imaging Stress Test; Time; Tissues; Tracer; Ultrasonography; Vasospasm; Vendor; Venous Malformation; Weight-Bearing state; X-Ray Computed Tomography

Clinicians rely on neuroimaging to visualize life-changing diseases affecting the brain. Current techniques struggle in areas important for neuroimaging such as quantifying cerebrovascular disease, detecting diseases of inflammation, and monitoring newly developed cell-based therapies. This is due to fundamental technical limitations in MRI, CT, and nuclear medicine. For example, CT perfusion imaging suffers from intrinsically poor signal-to-noise ratio (SNR), which translates to low image resolution and poor quantification that prevents identification of smaller strokes and vasospasms. A new clinical modality that provides fundamentally new information would present new opportunities for medicine. Magnetic Particle Imaging (MPI) is an emerging tracer imaging technology that excels at detecting functional measures such as perfusion. The MPI technique directly images superparamagnetic iron oxide (SPIO) tracers by measuring their time-varying magnetization in response to safe, low-frequency magnetic fields. MPI images are direct views of tracer distribution with no signal arising from tissue, no perturbations from materials such as air, and image intensity that is directly linear with tracer concentration. This “hot-spot” contrast provides spatial localization and quantification without ambiguity. In clinical neuroimaging, MPI can be used for real-time quantitative perfusion imaging, measurement of cerebrovascular reserve, and assessing vessel lumen diameters. MPI excels at measuring dynamic contrast enhancement and enhanced permeability and retention in tumors, and MPI's properties are near-ideal for cell tracking. In Phase I we explored multiple clinical magnet designs, estimated system cost, developed a manufacturing plan, and manufactured a small-scale preclinical system. In Phase II, we propose building the first human MPI imager. We will build the main magnet, characterize its magnetic performance, integrate all necessary support systems (shielding, RF transmit and receive, magnet control systems, etc.), characterizing the imager with phantoms, and finally evaluate with animal cadavers.

Public Health Relevance Statement:
Narrative Magnetic Particle Imaging (MPI) is a new imaging modality whose unique contrast, safety, and speed solves several limitations and concerns of current neurovascular imaging protocols. Here we propose to develop the first cerebrovascular MPI imager offering an alternative and new modality to allow safe assessment, staging and monitoring of neurovascular diseases such as stroke, aneurism and other vaso-malformations. Successful completion of a human brain MPI imager will mark the beginning of a new field of diagnostic imaging comparable in scope to the introduction of MRI, CT, or Ultrasound.

NIH Spending Category:
Bioengineering; Biomedical Imaging; Cerebrovascular; Drug Abuse (NIDA only); Neurosciences; Substance Abuse

Project Terms:
3-Dimensional; Abattoirs; Affect; Air; Amplifiers; Angiography; Animals; Area; Beds; Brain; Cadaver; Caliber; Cell Therapy; Cells; cerebrovascular; Cerebrovascular Disorders; Climacteric; Clinical; Computer software; contrast enhanced; cost; design; Development; Diagnostic Imaging; Discipline of Nuclear Medicine; Disease; Documentation; Equipment; Family suidae; Frequencies; Funding; Head; Hot Spot; Human; Image; imager; imaging modality; imaging properties; imaging system; Imaging Techniques; Imaging technology; Industry; Inflammation; innovation; Iron; iron oxide; Liquid substance; magnetic field; Magnetic Resonance Imaging; Magnetism; malformation; man; manufacturability; Measurement; Measures; Medicine; millimeter; Modality; Monitor; Motor; National Institute of Drug Abuse; neuroimaging; neurovascular; New Territories; Noise; operation; particle; Pathology; Patients; Performance; Perfusion; perfusion imaging; Permeability; Pharmaceutical Preparations; Phase; Physics; Physiologic pulse; Power Sources; pre-clinical; prevent; Protocols documentation; radio frequency; reconstruction; Resolution; response; Rotation; Safety; Salvelinus; scale up; Series; Shoulder; Signal Transduction; simulation; Slice; Speed; Staging; Stroke; Structure; superparamagnetism; Support System; System; targeted delivery; Techniques; Temperature; Testing; theranostics; Thermal Ablation Therapy; Time; Tissues; tool; Tracer; Translating; tumor; Ultrasonography; Vasospasm; Water; Work; X-Ray Computed Tomography