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影像学中最具挑战性的问题之一。视场、询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性。为此，我们建议进一步开发一种利用称为调制成像（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，从而定量了解疾病进展和治疗反应。我们相信这项技术在急慢性伤口评估方面的应用价值将会特别强。调制成像采用模式照明，以非侵入性地获得生物组织的地下图像。最近在美国国立卫生研究院/NIBIB P41生物医学技术资源中心的激光和医疗微束计划（LAMMP）下开发的这种非接触式方法可以在宽视野范围内快速、定量地确定组织的光学特性。当与多光谱成像相结合时，MI可用于定量确定与组织健康相关的发色团的体内浓度，即氧和脱氧血红蛋白和水。调制成像可以使用消费级电子设备执行，例如目前用于数码相机和DLP投影仪的电子设备。因此，考虑调制成像作为一种相对廉价的医疗设备的潜力是合理的。该提案的总体目标是开发一个强大的、用户友好的MI平台，能够在宽视野（25 x 34 cm）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快速（即< 15个时间尺度）和局部（即<1毫米）事件，在厚组织中深度为几毫米，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，实现交钥匙临床研究。建议的研究将包括以下步骤：1)设计和制造一个临床准备的调制成像硬件平台，该平台具有更大的视场，频谱复用，提高稳定性和易用性；2)开发具有自动分析和精细算法的临床友好软件；3)制定和执行内部和外部验证和验证流程和程序。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。在成功完成本文所述的II期研究后，我们打算严格进行III期临床研究，510(k)设备许可以及最终OxImager产品的最终商业化。