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

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.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43DA041814-01A1
Application #
9049379
Study Section
Special Emphasis Panel (ZRG1-SBIB-T (10))
Program Officer
Sazonova, Irina Y
Project Start
2015-09-15
Project End
2016-08-31
Budget Start
2015-09-15
Budget End
2016-08-31
Support Year
1
Fiscal Year
2015
Total Cost
$223,825
Indirect Cost
Name
Magnetic Insight, Inc.
Department
Type
DUNS #
078791637
City
Berkeley
State
CA
Country
United States
Zip Code
94703
Tay, Zhi Wei; Chandrasekharan, Prashant; Chiu-Lam, Andreina et al. (2018) Magnetic Particle Imaging-Guided Heating in Vivo Using Gradient Fields for Arbitrary Localization of Magnetic Hyperthermia Therapy. ACS Nano 12:3699-3713