SYMBION RESEARCH INTERNATIONAL — Department of Health and Human Services SBIR Phase I: DESCRIPTION (provided by applicant): Iron overload is a common problem in many population

Description

DESCRIPTION (provided by applicant): Iron overload is a common problem in many populations, resulting from hyperabsorption and blood transfusions. In recent years, magnetic resonance imaging (MRI) has been validated as a direct surrogate for tissue iron burden in liver and heart. More importantly, MRI has been clinically validated as an early predictor for cardiac and endocrine dysfunction, allowing intensified iron chelation therapy prior to organ damage. However current commercial software solutions foriron analysis lack standardization/validation and require high licensing costs, limiting widespread adoption. It is critical to address these shortcomings, especially because iron overload is not limited to the hemoglobinopathies. Significant hepatic siderosis is being demonstrated in many survivors of common malignancies. Iron overload influences insulin sensitivity in dysmetabolic iron overload syndrome. Greater recognition of interactions between iron, inflammation, and infection has increased the demandfor iron quantification applications by MRI. This work will establish a single software platform providing a generally adoptable, cost-effective solution for Thalassemia centers globally, to meet a broad range of clinical and research needs. We propose aunified and novel solution by combing reference lab (RL) and point-of-care (POC) processing/validation business models. During Phase-I, we will develop the key MRI iron-quantification software tools and standard operating procedures, validating them withpreviously acquired iron studies. Furthermore, we will establish performance metrics including inter-observer variability. Our Phase-II goals are to establish a collaborative consortium network of clinical research users of the iron load quantification biomarker and to perform optimization and clinical trial evaluation of the software for obtaining FDA 510(k) device clearance. These efforts will translate a well-validated research technology into a routine clinical test as well as offer greatly expanded opportunities for clinica research by incorporating the software with our CoreGrid image management platform. Clinical data can be pooled easily and securely among institutions facilitating increased investigator and industry-sponsored trials benefitting from MRI iron quantification. The software also provides unprecedented infrastructure to monitor the longitudinal consequences of iron overload across centers/consortia, providing a significant competitive advantage over other software platforms. Lastly, although this proposal focuses on MRI iron quantification, the concepts are generalizable to other types of image quantification such as myocardial mass, strain, or volume measurements. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Magnetic resonance imaging (MRI) has been validated as a direct non-invasive surrogate biomarker for tissue iron burden proving enormous potential for public health application associated with interactions between iron, inflammation, and infection. Creating a cost-effective and simple unified software platform for clinical and research centers presents an unprecedented solution to measure, validate, and monitor the longitudinal consequences of iron overload. This proposal, although focused on MRI iron quantification,can have broader and more generalizable applications to other types of image quantification such as myocardial mass, strain, or volume measurements.