Reflectance confocal microscopy-optical coherence tomography (RCM-OCT) imaging of oral lesions: Toward an affordable device and approach for developing countries

口腔病变的反射共焦显微镜-光学相干断层扫描 (RCM-OCT) 成像：为发展中国家提供负担得起的设备和方法

• 批准号: 10735695
• 负责人: Pankaj Chaturvedi
• 金额: $ 72.87万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-15 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10735695
• 关键词: Adoption; Adult; Africa; Africa South of the Sahara; Algorithms; Architecture; Asia; Atypia; Benign; Biopsy; Caliber; Cancer Center; Carcinoma; Caring; Cellular Morphology; Central Asia; Cessation of life; Clinic; Clinical; Code; Confocal Microscopy; Connective Tissue; Detection; Developing Countries; Devices; Diagnosis; Diagnostic; Dysplasia; Engineering; Epithelial Attachment; Epithelium; Erythroplasia; Fibrosis; Fright; Future; Guidelines; Head and Neck Surgery; Head and neck structure; Healthcare; Hospitals; Image; Imaging Device; Imaging Techniques; Incidence; India; Industry; Invaded; Investments; Lamina Propria; Lesion; Leukoplakia; Malignant - descriptor; Malignant Neoplasms; Memorial Sloan-Kettering Cancer Center; Monitor; New York; Operative Surgical Procedures; Optical Coherence Tomography; Oral; Oral Diagnosis; Oral Medicine; Oral cavity; Pain; Pathology; Patient Care; Patients; Population; Prevalence; Protein Structure Initiative; Public Health; Reporting; Severities; Skin Cancer; Specificity; Stratification; Testing; Time; Triage; Underserved Population; Validation; Visit; Visual; World Health Organization; cancer care; cancer diagnosis; care costs; care delivery; cellular imaging; clinical examination; compliance behavior; cost; design; design,build,test; diagnosis standard; follow-up; image guided; imaging approach; imaging capabilities; imaging detection; in vivo; innovation; intraoral probe; keratinization; laptop; low and middle-income countries; malignant mouth neoplasm; manufacture; meter; microscopic imaging; non-invasive imaging; novel; optical imaging; oral dysplasia; oral lesion; outreach clinics; physical science; portability; prospective test; reflectance confocal microscopy; research clinical testing; scale up; socioeconomics; success; timeline

High rates of incidence and prevalence of oral cancers occur in 15-20 developing low-and-middle income countries (LMICs) in Asia and Africa. Visual clinical examination followed by biopsy is the standard for diag- nosing oral lesions. But the low and variable specificity of 16-100% of visual examinations results in biopsies of an estimated 37-51% indeterminate lesions (1.4-2.1 million lesions in India, alone) and in benign-to-malig- nant biopsy ratios of 2-24. Patient compliance for biopsy and follow-up care is low (35-63%) in LMIC settings due to pain, fear, time and cost. Our novel solution is noninvasive imaging with a low-cost handheld reflec- tance confocal microscopy (RCM) - optical coherence tomography (OCT) device. Diagnosis and grading of oral dysplasia are based on cellular atypia in the epithelium and underlying architectural changes. RCM imag- ing shows cellular morphology in the entire epithelium to depth of 300 µm. OCT imaging shows epithelial lay- ers and underlying lamina propria to deeper depth of 1 mm. Combined RCM-OCT imaging with a single de- vice will enable simultaneous imaging of cellular atypia and architectural changes in co-located fields of view to guide diagnosis, grade dysplasia, monitor progression to malignancy and assess invasion. Stratification, with a quantitative RCM-OCT scoring algorithm, will guide triage of oral lesions into low-grade dysplasia, which can be monitored or immediately treated with non-surgical therapies, versus high-grade, which may be immediately biopsied, versus carcinoma, which will be surgically excised. Diagnosis may be combined with treatment, all integrated in a single patient visit - a “one stop shop” patient care paradigm. We are an academic-industry team at Memorial Sloan Kettering Cancer Center (New York, NY), Physical Sciences Inc. (Andover, MA), Cali- ber Imaging and Diagnostics (Rochester, NY) and our LMIC collaborators at Tata Memorial Hospital (TMH, Mumbai). For FOA PAR-21-166, innovation is defined to be “likelihood of delivering a new capability to end- users.” Innovations will be in delivering an RCM-OCT device with a new probe for intra-oral imaging and in designing a quantitative diagnostic scoring algorithm to guide diagnosis and treatment, in real-time, at the bed- side. The device will be delivered to TMH and will ultimately cost $25,000, when scaled up and locally manu- factured in LMICs, which will support dissemination of RCM-OCT as a new and affordable imaging capability in LMICs. In preliminary studies, RCM-OCT imaging detected oral lesions and cancers with sensitivity of 100% and specificity of 80%. Our specific aims are (1) to design a handheld RCM-OCT device for imaging in the oral cavity; (2) to prospectively test on 4,422 patients for diagnosis, grading of dysplasia and assessment of invasion in oral lesions and cancers in vivo. Testing will be in LMIC settings, at TMH in Mumbai and in their regional clinic in Varanasi. Affordability, delivery of care in LMICs: the return-on-investment on our device can be in 6-9 months at cancer centers, while the cost of care to deserving patients can be as little as zero to 50 cents for the imaging procedure. Our initial success in India will seed global effort in LMICs.

15-20的低水平癌症发生率高和口服癌症的患病率很高 亚洲和非洲的国家（LMIC）。视觉临床检查然后进行活检是诊断的标准 口腔病变。但是16-100％的视觉检查的低和可变特异性导致活检 估计有37-51％的不确定病变（仅在印度，仅1.4-210万个病变）和良性到麦利组织 南特活检比为2-24。在LMIC设置中，患者的活检和随访护理的依从性较低（35-63％） 由于痛苦，恐惧，时间和成本。我们的新颖解决方案是具有低成本手持式反射的无创成像 音质共聚焦显微镜（RCM） - 光学相干断层扫描（OCT）设备。诊断和分级 口腔发育不良基于上皮和潜在的结构变化的细胞异型。 RCM Imag- ING显示了整个上皮的细胞形态至300 µm的深度。 OCT成像显示上皮层 - ERS和底层椎板过渡至1 mm的深度。将RCM-OCT成像结合在一起 VICE将同时进行细胞异型的成像，并在共同位置的视野中的结构变化到 指导诊断，成绩不适，监测到恶性肿瘤和评估入侵。分层，与 定量的RCM-OCT评分算法，将指导口腔病变分类为低度发育不良，可以 与高级相比，接受非手术疗法的监测或立即治疗，可能会立即 与癌相比，活检将超过手术。诊断可能与治疗相结合，所有 集成在一次患者访问中 - “一站式商店”患者护理范式。我们是一个学术行业 纪念斯隆·凯特林癌症中心（纽约，纽约）的团队，物理科学公司（马萨诸塞州安多弗），加利福尼亚 Ber Imaging和Diagnostics（纽约州罗切斯特）和我们的LMIC合作者在Tata Memorial Hospital（TMH，TMH， 孟买）。对于FOA PAR-21-166，创新被定义为“发挥新的能力来结束的可能性 用户。”创新将是通过使用新的口腔内成像和IN的新探针交付RCM-OCT设备 设计定量诊断评分算法，以实时指导诊断和治疗 边。该设备将被交付到TMH，最终将花费25,000美元，并在本地进行缩放并在本地制造。 在LMIC中构成，它将支持将RCM-OCT传播为新的且负担得起的成像能力 LMICS。在初步研究中，RCM-OCT成像检测到口服病变和癌症的敏感性为100％ 和80％的特异性。我们的具体目的是（1）设计用于成像的手持式RCM-OCT设备 口腔； （2）前瞻性测试4,422名患者的诊断，发育不良的评分和评估 口腔病变和体内癌症的入侵。测试将在LMIC设置，在孟买的TMH和他们的 瓦拉纳西区的区域诊所。负担能力，LMIC的护理交付：我们设备上的投资回报 可以在癌症中心的6-9个月内，而应得的患者的护理费用只有零 成像过程的50美分。我们在印度的最初成功将使全球LMIC的努力播种。