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Salem, NH, United States

Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase II | Award Amount: 1.73M | Year: 2008

DESCRIPTION (provided by applicant): The focus of this proposal is the development of a novel in-vivo imaging device (Molecular Breast Imaging system) that incorporates a clinical validation experiment and a limited pilot and a clinical feasibility evaluation for pre-clinical and clinical studies. Our primary intent is to facilitate the proof of feasibility of this novel imaging device for early detection, diagnosis, and treatment monitoring of breast cancer. The purpose of this imaging system is to define the characteristics of breast cancer at a molecular level using both established and novel radioactive markers that can enable the early detection and monitor the treatment of breast cancer. The novelty of this system is two fold: 1) development of a system that will comprise two opposing Cadmium Zinc Telluride (CZT) semi-conductor detectors in a specialized gantry, and 2) development of algorithms and corresponding clinical software packages that will permit absolute quantitation of tumor uptake of radiopharmaceuticals and permit monitoring of the kinetics of uptake and washout of radiopharmaceuticals in breast tissue. It is our primary goal in this Fast Track STTR proposal to create clinical tools, dual-headed breast imaging system (to be developed by GM) and software for quantitative analysis of the image data (Mayo) for functional breast imaging. Our secondary goal is demonstrate the ability of the camera to be utilized as a preclinical research device. Each facility will complete small patient trials to illustrate the potential application of this device and associated software in the evaluation of new radiopharmaceuticals for detection of breast cancer. During the Phase I of this Fast Track STTR we will construct a fully functional Dual Headed CZT breast imaging camera complete with Acquisition, Processing, Tumor Quantification, and simultaneous dual Isotope Capabilities. One tested prototype camera will be built during Phase-I and two additional cameras will emulate the original and their assembly will take place during Phase-II. During Phase-II of this proposal the primary goal is to evaluate the clinically usefulness of a dual-headed breast imaging system (to be developed by GM) and software for quantitative analysis of the image data (to be developed by Mayo). This will be accomplished through a multi-center pilot study. Three sites will conduct a patient study that will validate the ability of this device to detect sub-10 mm breast lesions. The secondary goals are 1) to compare the diagnostic capabilities of this device to MRI, 2) to explore the potential application of this device in dual-isotope studies, and 3) to demonstrate its ability to evaluate new promising radiopharmaceuticals. The secondary goals will be accomplished during Phase II and will be undertaken at all three clinical sites.


Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase I | Award Amount: 202.00K | Year: 2007

DESCRIPTION (provided by applicant): The focus of this proposal is the development of a novel in-vivo imaging device (Molecular Breast Imaging system) that incorporates a clinical validation experiment and a limited pilot and a clinical feasibility evalua tion for pre-clinical and clinical studies. Our primary intent is to facilitate the proof of feasibility of this novel imaging device for early detection, diagnosis, and treatment monitoring of breast cancer. The purpose of this imaging system is to define the characteristics of breast cancer at a molecular level using both established and novel radioactive markers that can enable the early detection and monitor the treatment of breast cancer. The novelty of this system is two fold: 1) development of a syst em that will comprise two opposing Cadmium Zinc Telluride (CZT) semi-conductor detectors in a specialized gantry, and 2) development of algorithms and corresponding clinical software packages that will permit absolute quantitation of tumor uptake of radiop harmaceuticals and permit monitoring of the kinetics of uptake and washout of radiopharmaceuticals in breast tissue. It is our primary goal in this Fast Track STTR proposal to create clinical tools, dual-headed breast imaging system (to be developed by GM) and software for quantitative analysis of the image data (Mayo) for functional breast imaging. Our secondary goal is demonstrate the ability of the camera to be utilized as a preclinical research device. Each facility will complete small patient trials to illustrate the potential application of this device and associated software in the evaluation of new radiopharmaceuticals for detection of breast cancer. During the Phase I of this Fast Track STTR we will construct a fully functional Dual Headed CZT breas t imaging camera complete with Acquisition, Processing, Tumor Quantification, and simultaneous dual Isotope Capabilities. One tested prototype camera will be built during Phase-I and two additional cameras will emulate the original and their assembly will take place during Phase-II. During Phase-II of this proposal the primary goal is to evaluate the clinically usefulness of a dual-headed breast imaging system (to be developed by GM) and software for quantitative analysis of the image data (to be developed by Mayo). This will be accomplished through a multi-center pilot study. Three sites will conduct a patient study that will validate the ability of this device to detect sub-10 mm breast lesions. The secondary goals are 1) to compare the diagnostic capabili ties of this device to MRI, 2) to explore the potential application of this device in dual-isotope studies, and 3) to demonstrate its ability to evaluate new promising radiopharmaceuticals. The secondary goals will be accomplished during Phase II and will be undertaken at all three clinical sites.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 355.38K | Year: 2007

Not avaiable.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 578.90K | Year: 2007

DESCRIPTION (provided by applicant): Commercially available microCT (computed tomography) systems have failed to meet the challenging demands for small animal imaging, beyond the single requirement for good spatial resolution. Specifically, they have failed to take into account that the thousand times smaller volume in mice, compared to humans, is also coupled with ten times faster heart rates, and increased respiratory rates and circulation times. Thus, the currently available systems have been limited to either: (1) in-vivo volume CT, which is primarily useful for co-registration of anatomical and with functional images provided by positron emission tomography (PET) or single photon emission computer tomography (SPECT); or (2) ex-vivo high spatial resolution CT, with sufficient contrast resolution for specimen imaging. However, these commercial systems have all failed to address the significant pre-clinical applications for micro-CT, which require improved tissue contrast, lower dose, and faster acquisition times to allow for dynamic images acquired in small animals and to take full advantage of the use of contrast agents. The goal of this project is to develop a next generation microCT for pre-clinical imaging for drug development and medical research. The system will be designed to provide clinical quality CT images in vivo in mice and rats, with performance specifications optimized to accommodate the demanding requirements of the most critical areas of current medical research. Specifically, the instrument will provide very good spatial resolution, ultra fast frame speeds (< 1 second), and low radiation dose to the subject. This will be achieved utilizing a photon counting mode for x-ray acquisition, instead of the standard current integration mode. The system will be capable of gross energy information and energy binning, and thus will provide "Color-CT(tm)" capability, allowing tissue compositional analysis. To accomplish these advances, the system will feature advanced CdTe solid state detectors, coupled to high speed integrated circuits for signal processing, to achieve performance characteristics not currently possible from conventional technologies used by the major CT manufacturers. In Phase-II, a fast dynamic multi-slice Color-CTTM scanner prototype will be developed, employing multiple detector modules in a novel system design incorporating a very fast x-ray source. This new modality, once established in the microCT marketplace, will undoubtedly translate into human CT scanners, and given the current study volumes of clinical CT, the impact that this project imparts to the field of medical imaging will indeed be dramatic.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 3.00M | Year: 2009

DESCRIPTION (provided by applicant): Molecular Breast Imaging to Guide Early-Stage Patient Care Molecular Breast Imaging (MBI) will one day provide decision guidance for patient management without the need to perform a biopsy - that is without the need to cut out tissue that often is found to be normal. MBI's future benefit to women's health will obviate stressful watching and waiting periods of months, and will guide chemotherapy or surgery decisions toward optimized outcomes. A suspicious growth is often seen in conventional mammography by casting its shadow on film. However, often the shadow becomes inconspicuous in the background of dense but normal tissues. MBI forms images through a completely different process: drugs of trace amounts are taken up in the abnormal tissues, and then shine gamma-rays out to an imaging instrument located near the breast. These imaging drugs, also known as biomarkers , can be selected to probe specific biological processes of immediate concern to the physician. For example, the aggressiveness or invasiveness of a tumor can be probed by a biomarker designed to specifically target cellular proliferation (i.e., the rate of cell division and tissue growth). Other biomarkers can light up tumors featuring specified hormone receptors or other identifying cellular features known to be associated with certain types of cancer. One of these processes, namely the metabolic rate of proliferative cellular functions, is probed by the imaging agent known as 99mTc-sestamibi ( MIBI for short). This agent was associated with breast cancer in the 1990s through the use of an imaging instrument known as the Anger camera . This device, which was designed in 1957, has flexible utility in imaging any organ (from prostate to brain) as well as whole bodies. Only in recent years has the Anger camera been specially designed for imaging of an organ, namely the heart. The current proposal describes another specially designed camera, the Molecular Breast Imager, which forms images using a new, dual-head solid state detector that is a distinct improvement over the 52-year old Anger method. This detector has been developed by the applicant institution, Gamma Medica- Ideas (GM-I, Northridge, CA) in collaboration with researchers at the Mayo Clinic. Clinical trials conducted by Dr. O'Connor of the Mayo Clinic (one of the investigators on this project) demonstrate results that are superior to mammography for women with dense breasts - i.e., those women in whom shadows are difficult to cast. Dr. O'Connor also has shown MBI to be very specific, that is, resulting in few false positives that would lead to worrisome yet normal biopsy. The current proposal describes a program run by Gamma Medica-Ideas and involving clinical research collaborations at the Mayo Clinic, Cedars-Sinai Medical Center, and Harbor-UCLA. The aims are to commercialize the dual-head MBI scanner, to strengthen the case for routine use of MIBI for well-defined populations of women, and to associate new biomarkers with patients and disease stage such that subsequent decisions are non-invasively guided by MBI results. PUBLIC HEALTH RELEVANCE: Molecular Breast Imaging to Guide Early-Stage Patient Care Non-invasive molecular imaging promises to benefit breast cancer patient care while reducing costs and uncertainties. This will be achieved by the screening of selected, at-risk populations of women and providing definitive diagnosis and therapy guidance. We propose a commercialization program for a highly accurate instrument capable of imaging molecular imaging agents at the earliest, most treatable stage of breast cancer, thereby optimizing decision making toward improved and cost-effective outcomes

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