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BIRMINGHAM, AL, United States

Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 99.28K | Year: 1997

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Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 131.48K | Year: 2008

DESCRIPTION (provided by applicant): The overall goal of this project is to develop and commercialize a software package to be interfaced with commercial MRI scanners providing physicians with an immediately available diagnostic tool for noninvasive detec tion, lateralization, and quantification of epileptogenic tissue. This software would convert a set of 2D MRI images of the brain to a 3D percent-pathology map (PPM) with a voxel-by-voxel resolution and offer more patients with epilepsy the prospect of a d efinitive surgical cure. The techniques implemented and clinically validated in this Phase I proposal would ultimately be developed into the software package and fully validated in a future Phase II proposal. The main target market for this package will be the major manufacturers of MRI scanners. Assessment of pathology is crucial in the pre-surgical evaluation of epilepsy patients, of which, mesial temporal lobe epilepsy (MTLE) patients with hippocampal pathology are the most common. In epilepsy patients w ith a clear hippocampal lesion such as mesial temporal sclerosis identified by MRI, surgical resection can be curative. Presently available clinical diagnostic MRI, however, fails to identify such a lesion in about 30% of such patients. About half of these MRI-negative patients nevertheless do have a distinct pathological lesion discovered post-surgically. Surgery on patients with MRI negative epilepsy is associated with poorer post- surgical outcome. The identification of subtle or early abnormalities, presently undetected by MRI but potentially detectable by our method, could help guide the neurosurgeon in selection of tissue for resection. This should lead to improved treatment of patients with epilepsy. The objective of this Phase I proposal is to ge nerate preliminary data that supports the assertion that our method provides the means for noninvasive lateralization and quantification of epileptogenic brain tissue in MRI-negative MTLE. This preliminary data would then be used for a future Phase II pr oposal. This objective will be achieved via these Aims: 1) Generate the PPMs from MRI images in ten MTLE patients with positive conventional diagnostic MRIs (positive controls), ten normal subjects (negative controls), and ten MRI-negative MTLE patients. F or comparison to a presently available and commonly used technique, T2 maps will also be generated for each subject. 2) Validate in MTLE patients that PPMs can reliably detect and lateralize epileptogenic hippocampal tissue by comparing the PPMs to the gol d standard: intracranial electroencephalography. To show the superiority of our method over presently available MRI methods, head to head comparison will be also made with T2wSI and T2 mapping. 3) Validate in MTLE patients that PPMs yield quantitative info rmation on the degree of hippocampal pathology by comparing our MRI measure of pathology to the gold standard: post-surgical histopathological examination of resected hippocampal tissue.


Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase II | Award Amount: 380.81K | Year: 2007

DESCRIPTION (provided by applicant): The overall goal of this Phase II project is to develop a novel R1-based method for MRI quantification of postinfarct myocardial viability using a commercially available contrast agent Gd(DTPA). The commercial embodiment of this method will be a software package that will convert a set of 2D cardiac MRI images to a 3D myocardial viability map, the Percent Infarct Map (PIM) with a voxel-by-voxel resolution. In ultimate human clinical use, the package would be interfaced with commercial MRI scanners providing physicians with an immediately available diagnostic tool at the end of the scanning session. The main target market for this package will be either the major manufacturers of MRI scanners or an established company that creates and markets cardiac MRI software. We already have had interest expressed in our plans by one such major company, Medis (see letter from Medis). Assessment of viability is crucial in the monitoring of myocardial infarction (MI). A high spatial-resolution method that can distinguish quantitatively between areas of infarct and viable islets in the infarct areas would be useful for clinical decision making. The objective of Phase I was the validation (with statistical significance), in a canine model of reperfused MI, of the PIM method to provide a reliable viability maps in the canine model of reperfused MI. PIM was also compared with the current MRI standard, Delayed Enhancement (DE), in the same dogs and MRI sessions, to ensure comparison at the same time point. All objectives of Phase I have been achieved: PIM yielded accurate quantitative information about infarct size and distribution, agreed with the pathology gold standard, TTC-staining histochemistry, and was superior to DE. While the primary aim of the Phase II project will be the development and testing of the software package itself, we also want to enhance the desirability of this package in the eyes of clinicians so that market demands for it would be optimized. Clinical usefulness depends on the reliability of a technique not just at a single selected time point along the evolution of infarct, but rather at all relevant time points of infarct tissue development, both reperfused and non-reperfused. Thus we plan to demonstrate the utility of the package at several crucial time points of infarct evolution in both reperfused and non-reperfused myocardial infarction models. To aid in coregistration of MRI and histology, based on the success in Phase I. studies, we will also incorporate ex-vivo imaging and histology to validate our findings with MRI and the post-processing software.


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Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 719.26K | Year: 1999

N/A


Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase I | Award Amount: 100.00K | Year: 2005

DESCRIPTION (provided by applicant): The overall goal of this project is to develop a novel method for MRI quantification of postinfarct myocardial viability. Ultimately, the commercial embodiment of this method will be a software package that will convert a set of 2D cardiac MRI images to a 3D Myocardial Viability Map (MV) with a voxel-by-voxel resolution. In human clinical use, the package would be interfaced with commercial MRI scanners providing physicians with an immediately available diagnostic tool at the end of the scanning session. The main target market for this package will be the major manufacturers of MRI scanners. Assessment of viability is crucial in the monitoring of myocardial infarction (Ml). A high spatial-resolution method that can distinguish quantitatively between areas of infarct and viable islets in the infarct areas would be useful for clinical decision making. The objective of Phase I is the validation, in a canine model of reperfused Ml, of our method to provide a reliable MV based on MRI. This objective will be achieved via the Specific Aims: 1) Validate in the canine model of reperfused Ml (in 10 dogs) that MV can yield quantitative information on the distribution of viable areas. "Native" images, i.e. images without the application of contrast agent (CA), will be used to test the reliability of maps obtained unaided by contrast enhancement. 2) Compare the MV with the current MRI standard, Delayed Enhancement, in the same dog and MRI session, to ensure comparison at the same time point. 3) Same as Aim 1, except that a single slice MV will be generated after bolus administration of 0.2 mmol/kg of the CA, Magnevist. 4) Same as Aim 1, except MV will be obtained during continuous CA infusion, maintaining a steady state agent concentration in the tissue to allow mapping of the entire left ventricle. 5) Compare the MV with the pathology gold standard, TTC-stained histology. TTC perfusion of the same dogs as above will be carried out at the end of the MRI session and heart will be immediately excised for histology, to ensure comparison with the in vivo results at the same time point.

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