The overall goal of this SBIR Phase II proposal is to refine and evaluate advanced quantitative magnetic resonance imaging (MRI) phantoms that mimic the simultaneous presence of fat, iron and fibrosis. Fat, iron and fibrosis are three principal histological coexisting features of many important disease states. Phantoms are highly controlled test objects that accurately reflect tissue characteristics in both normal and pathological tissues. Emerging quantitative MRI methods introduced in the past ~5 years are increasingly used for non- invasive diagnosis, staging and treatment monitoring in both clinical care and clinical trials. However, the lack of viable MRI phantoms that mimic the combination of fat, iron and fibrosis experienced in disease states is a major barrier to the development of new quantitative MRI biomarkers, as well as effective quality assurance in clinical environments. Such phantoms are also needed for quality assurance and qualification of MRI scanners for use in multicenter drug development trials. This collaborative Phase II proposal between Calimetrix, LLC, and the University of Wisconsin-Madison will build upon the successful proof-of-concept prototype developed in an STTR Phase I project. Specifically, this proposal will refine and evaluate novel quantitative MRI phantoms for the validation and quality assurance of MRI techniques to assess fat, iron and fibrosis in tissue. The investigative team will optimize and determine the manufacturing accuracy of the phantom (Aim 1), as well as its manufacturing precision (Aim 2), will conduct accelerated shelf-life testing (Aim 3), and will evaluate the phantom in a multi-center study across various sites, MRI vendors, and two field strengths (Aim 4). Successful design, development and validation of advanced phantoms that accurately reflect tissue characteristics are a critical step in the development and dissemination of quantitative imaging biomarkers, which will have major impact by reducing cost, improving safety, and improving early diagnosis and treatment of disease, affecting the health of millions of Americans.
The broad, long-term objective of our research is to improve the health of millions of Americans who suffer from chronic diseases such as nonalcoholic fatty liver disease, iron overload, and fibrosis. New magnetic resonance imaging methods are able to quantify important disease features, providing non-invasive ways to evaluate the presence and severity of a variety of diseases. The development and implementation of such quantitative imaging methods requires highly controlled and reliable test objects, or ?phantoms?, that accurately mimic the presence of disease - this proposal aims to refine and evaluate a novel MRI phantom.
