Modulated Imaging: A Wide-field Optical Imaging Platform for Clinical Research

描述(申请人提供)：组织结构和功能的定量表征是医学成像中最具挑战性的问题之一。视场、讯问深度和分辨率是显著影响图像质量和信息内容的关键特征。为此，我们建议进一步开发一种利用一种称为调制成像(MI)的新成像技术的设备，并对该设备的灵敏度进行基准测试，以提供可用于确定体内组织状态的客观参数，从而能够定量了解疾病进展和治疗反应。我们相信，这项技术在急性和慢性伤口评估中的应用价值将特别大。调制成像利用图案化照明来非侵入性地获得生物组织的亚表面图像。这种非接触式方法是在NIH/NIBIB P41生物医学技术资源中心激光和医学微束计划(LAMMP)下最近开发的，能够在广泛的视野内快速、定量地确定组织的光学特性。当与多光谱成像相结合时，MI可以用来定量地确定与组织健康相关的生色团的体内浓度，即氧合和脱氧血红蛋白和水。调制成像可以使用消费级电子设备来执行，例如目前在数码相机和DLP投影仪中使用的电子设备。因此，考虑将调制成像作为一种相对便宜的医疗设备来执行的可能性是合理的。这项提议的广泛目标是开发一个强大的、用户友好的MI平台，能够在大范围(25 x 34厘米)上进行定量成像，并适合在临床现场部署。它将具有足够的时空分辨率来研究厚组织中几毫米深度的快速(即&lt；1s时间尺度)和局部(即&lt；1 mm)事件，其应用领域包括慢性伤口愈合、压疮分期、烧伤评估和重建手术。为了实现这一目标，我们将为临床合作者设计和部署一个最终的MI系统平台，使其能够进行交钥匙临床研究。拟议的研究将包括以下步骤：1)设计和制造一个临床就绪的调制成像硬件平台，该平台具有更大的视野、光谱复用、更高的稳定性和易用性，2)开发具有自动分析和改进算法的临床友好软件，3)开发和执行内部和外部验证和验证过程和程序，以及4)进行体内评估，以建立定量血红蛋白和水参数恢复的性能和灵敏度基准。在成功完成本文概述的第二阶段研究后，我们打算严格进行第三阶段临床研究、510(K)设备许可以及我们最终的OxImager产品的最终商业化。

DESCRIPTION (provided by applicant): Quantitative characterization of tissue structure and function is one of the most challenging problems in Medical Imaging. Field of view, depth of interrogation, and resolution are critical features that dramatically impact image quality and information content. To this end, we propose to further the development of a device that exploits a new imaging technique known as Modulated Imaging (MI) and to benchmark the sensitivity of this device to provide objective parameters that can be used to determine status of in-vivo tissue, enabling quantitative insight into disease progression and therapeutic response. We believe the value of this technology will be particularly strong in its application toward acute an chronic wound assessment. Modulated Imaging employs patterned illumination to non-invasively obtain subsurface images of biological tissues. Recently developed under the Laser and Medical Microbeam Program (LAMMP), an NIH/NIBIB P41 Biomedical Technology Resource Center, this non-contact approach enables rapid, quantitative determination of the optical properties of tissues over a wide field-of-view. When combined with multi-spectral imaging, MI can be used to quantitatively determine the in-vivo concentrations of chromophores that are relevant to tissue health, namely, oxy- and deoxy-hemoglobin and water. Modulated Imaging can be executed using consumer grade electronics such as those currently employed in digital cameras and DLP projectors. Hence, it is plausible to consider the potential for Modulated Imaging to be executed as a relatively inexpensive medical device. The broad goal of this proposal is to develop a robust, user-friendly MI platform capable of quantitative imaging over a wide-field (25 x 34 cm) and appropriate for deployment at clinical sites. It will possess sufficient spatio-temporal resolution to study both fast (i.e., <1s timescale) and localized (i.e.,<1 mm) events at depths of several millimeters in thick tissues, with application areas such as chronic wound healing, pressure sore staging, burn assessment, and reconstructive surgery. To achieve this, we will design and deploy to clinical collaborators a final MI system platform enabling turn-key clinical research. The proposed research will include the following steps: 1) Design and fabricate a clinic-ready Modulated Imaging hardware platform with increased field-of-view, spectral multiplexing, improved stability and enhanced ease of use, 2) Develop clinic-friendly software with automated analysis and refined algorithms, 3) Develop and perform internal and external validation and verification processes and procedures and 4) Conduct in-vivo evaluations to establish benchmarks of performance and sensitivity for quantitative hemoglobin and water parameter recovery. Upon successful completion of the Phase II research outlined herein, we intend to rigorously pursue Phase III clinical studies, 510(k) device clearance and ultimate commercialization of our final OxImager" product.