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

调制成像：用于临床研究的宽视场光学成像平台

• 批准号: 8672597
• 负责人: David John Cuccia
• 金额: $ 74.41万
• 依托单位: MODULATED IMAGING, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-06-05 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8672597
• 关键词: Acceleration; Acute; Algorithms; Amputation; Area; Benchmarking; Biological; Biomedical Technology; Burn injury; Calibration; Caring; Chronic; Clinic; Clinical; Clinical Research; Collaborations; Computer software; Decubitus ulcer; Development; Device or Instrument Development; Devices; Diagnosis; Disease; Disease Progression; Early Diagnosis; Electronics; Engineering; Equilibrium; Evaluation; Event; Feedback; Figs - dietary; Frequencies; Future; Goals; Gold; Health; Hemoglobin; Hospitals; Human; Image; Imagery; Imaging Device; Imaging Techniques; Imaging technology; Institutes; Lasers; Learning; Light; Lighting; Maps; Measurement; Measures; Mechanics; Medical; Medical Device; Medical Imaging; Modeling; Monitor; Motion; National Institute of Biomedical Imaging and Bioengineering; Neonatal; Nurses; Optical Methods; Optics; Oryctolagus cuniculus; Patients; Pattern; Performance; Phase; Phototherapy; Physicians; Physiological; Physiology; Positioning Attribute; Preclinical Testing; Procedures; Process; Property; Reconstructive Surgical Procedures; Recovery; Research; Research Personnel; Resolution; Resources; Robin bird; Skin; Skin graft; Specific qualifier value; Speed; Staging; Structure; System; Technology; Testing; Therapeutic; Thick; Time; Tissues; Touch sensation; Translations; Trauma; United States National Institutes of Health; Validation; Water; Wound Healing; base; chromophore; clinical research site; commercialization; computerized data processing; design; diabetic; digital; flexibility; hemodynamics; imaging modality; improved; in vivo; innovation; insight; instrument; millimeter; operation; optical imaging; pre-clinical; programs; prototype; public health relevance; response; skin disorder; time use; user-friendly; verification and validation; wound

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.

描述（由申请人提供）：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。视野，审讯深度和解决方案是显着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新成像技术的设备的开发，称为调制成像（MI），并基于该设备的敏感性，以提供客观参数，可用于确定体内组织的状态，从而实现对疾病进展和治疗疗法反应的定量洞察力。我们认为，这项技术的价值将在急性慢性伤口评估中的应用中特别强大。 调制成像采用图案化的照明来非侵入性获得生物组织的地下图像。最近在NIH/NIBIB P41生物医学技术资源中心（LAMMP）（LAMMP）下开发的，这种非接触式方法可以快速，定量地确定组织的光学特性，而不是视野广泛的视野。当与多光谱成像结合使用时，MI可用于定量确定与组织健康相关（即氧和氧基 - 氧气 - 血红蛋白和水）的体体浓度。可以使用消费者级电子产品（例如数码相机和DLP投影仪中使用的）进行调制成像。因此，可以考虑将调制成像作为相对便宜的医疗设备执行的潜力是合理的。 该提案的广泛目标是开发一个能够在宽场（25 x 34厘米）上进行定量成像的强大，用户友好的MI平台，并适合在临床站点部署。它将具有足够的时空分辨率，可以快速研究（即，<1s时间尺度）和局部（即<1 mm）事件，在厚组织中几毫米的深度，以及慢性伤口愈合，压力疼痛，烧伤，烧伤评估和重建性手术等施用区域的深度。为了实现这一目标，我们将设计并部署到临床合作者的最终MI系统平台，以实现交钥匙临床研究。 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定量血红蛋白和水参数恢复的敏感性。在此处概述的第二阶段研究成功完成后，我们打算严格地进行III期临床研究，510（k）设备清除率和最终的Oximager“产品”的最终商业化。