VALIDATION OF TRANSILLUMINATION AND THE NEVOSCOPE

透射照明和电子显微镜的验证

• 批准号: 6549466
• 负责人: NIZAR A MULLANI
• 金额: $ 18.83万
• 依托单位: TRANSLITE, LLC
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2004-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6549466
• 关键词: angiogenesis; basal cell carcinoma; bioimaging /biomedical imaging; biomedical equipment development; clinical research; diagnosis design /evaluation; digital imaging; early diagnosis; human subject; imaging /visualization /scanning; luminescence; melanoma; neoplasm /cancer blood supply; neoplasm /cancer diagnosis; nevus; optics; pigments; skin disorder diagnosis; skin neoplasms

DESCRIPTION (provided by applicant): Skin cancer is the most common of all cancers and melanoma is a deadly skin cancer that accounts for over 75% of all the skin cancer deaths in the United States. The incidence of melanoma is rising at approximately 3% per year. Early detection of melanoma results in 95% cure rate. But, early detection of melanoma is difficult because of the subtle changes that differentiate a malignant melanoma from a benign mole. Better methods to detect these subtle changes, and more frequent screening for skin cancer, will significantly improve the early detection of melanoma and possibly reduce the number of deaths caused by this disease. Early detection of melanoma requires better methods for examining subtle changes in the pigmentation of the suspicious moles. Side-transillumination, whereby light is directed into the skin from around the suspicious mole, is a new method that makes the skin translucent so that the subsurface structures can be examined with clarity. This technique is used in a prototype device called the Nevoscope and has the potential for improving the early detection of skin cancers such as melanoma and basal cell carcinoma. The goal of this research project is to validate the use of side-transillumination for the detection of melanoma by comparing its detection accuracy to the established oil epiluminescence method. The second goal of the research project is to develop a commercial model of the Nevoscope for clinical use by the dermatologists that would be easy to use and affordable. The clinical validation study will digitally image 240 skin lesions suspicious for malignancy using the oil-based imaging and the side-transillumination imaging in the same lesion. Two dermatologists that are blinded to the patient history, and who will make a diagnosis based on a semi quantitative scoring method, will read these images. Diagnostic accuracy for melanoma will be computed for the two methods based on pathology-determined diagnosis of the excised lesion. The long-term goal of this research is to validate the side-transillumination method and develop the Nevoscope device into a commercial product for improved early diagnoses of skin cancers.

描述（由申请人提供）：皮肤癌是所有癌症中最常见的，黑色素瘤是一种致命的皮肤癌，占美国所有皮肤癌死亡人数的 75% 以上。黑色素瘤的发病率每年以大约 3% 的速度上升。早期发现黑色素瘤的治愈率高达 95%。但是，黑色素瘤的早期发现很困难，因为区分恶性黑色素瘤和良性痣的细微变化。更好的方法来检测这些细微的变化，以及更频繁地筛查皮肤癌，将显着改善黑色素瘤的早期检测，并可能减少由这种疾病引起的死亡人数。黑色素瘤的早期发现需要更好的方法来检查可疑痣色素沉着的细微变化。侧面透照是将光线从可疑痣周围引导到皮肤中，是一种使皮肤半透明的新方法，以便可以清晰地检查皮下结构。该技术用于名为 Nevoscopy 的原型设备，有望改善黑色素瘤和基底细胞癌等皮肤癌的早期检测。该研究项目的目标是通过将侧面透照法的检测精度与已建立的油落射发光方法进行比较，验证其在黑色素瘤检测中的使用。该研究项目的第二个目标是开发一种易于使用且价格实惠的 Nevscope 商业模型，供皮肤科医生临床使用。临床验证研究将使用油基成像和侧透成像对同一病变进行数字化成像，对 240 个疑似恶性肿瘤的皮肤病变进行成像。两名对患者病史不知情的皮肤科医生将根据半定量评分方法做出诊断，他们将读取这些图像。将根据切除病变的病理学确定的诊断来计算两种方法的黑色素瘤诊断准确性。这项研究的长期目标是验证侧面透照方法并将 Nevoscopy 设备开发成商业产品，以改善皮肤癌的早期诊断。