PDF(Pubmed)
Abstract：
UNASSIGNED: The elastic scattering spectroscopy (ESS) device (DermaSensor Inc., Miami, FL) is a noninvasive, painless, adjunctive tool for skin cancer detection.
UNASSIGNED: To investigate the performance of the ESS device in the detection of melanoma.
UNASSIGNED: A prospective, investigator-blinded, multicenter study was conducted at 8 United States (US) and 2 Australian sites. All eligible skin lesions were clinically concerning for melanoma, examined with the ESS device, subsequently biopsied according to dermatologists\' standard of care, and evaluated with histopathology. A total of 311 participants with 440 lesions were enrolled, including 44 melanomas (63.6% in situ and 36.4% invasive) and 44 severely dysplastic nevi.
UNASSIGNED: The observed sensitivity of the ESS device for melanoma detection was 95.5% (95% CI, 84.5% to 98.8%, 42 of 44 melanomas), and the observed specificity was 32.5% (95% CI, 27.2% to 38.3%). The positive and negative predictive values were 16.0% and 98.1%, respectively.
UNASSIGNED: The device was tested in a high-risk population with lesions selected for biopsy based on clinical and dermoscopic assessments of board-certified dermatologists. Most enrolled lesions were pigmented.
UNASSIGNED: The ESS device\'s high sensitivity and NPV for the detection of melanoma suggest the device may be a useful adjunctive, point-of-care tool for melanoma detection.
UNASSIGNED: To investigate the performance of the ESS device in the detection of melanoma.
UNASSIGNED: A prospective, investigator-blinded, multicenter study was conducted at 8 United States (US) and 2 Australian sites. All eligible skin lesions were clinically concerning for melanoma, examined with the ESS device, subsequently biopsied according to dermatologists\' standard of care, and evaluated with histopathology. A total of 311 participants with 440 lesions were enrolled, including 44 melanomas (63.6% in situ and 36.4% invasive) and 44 severely dysplastic nevi.
UNASSIGNED: The observed sensitivity of the ESS device for melanoma detection was 95.5% (95% CI, 84.5% to 98.8%, 42 of 44 melanomas), and the observed specificity was 32.5% (95% CI, 27.2% to 38.3%). The positive and negative predictive values were 16.0% and 98.1%, respectively.
UNASSIGNED: The device was tested in a high-risk population with lesions selected for biopsy based on clinical and dermoscopic assessments of board-certified dermatologists. Most enrolled lesions were pigmented.
UNASSIGNED: The ESS device\'s high sensitivity and NPV for the detection of melanoma suggest the device may be a useful adjunctive, point-of-care tool for melanoma detection.
摘要：
■弹性散射光谱（ESS）设备（DermaSensorInc.，迈阿密,FL)是非侵入性的，无痛,皮肤癌检测的辅助工具。
■研究ESS设备在检测黑色素瘤中的性能。
■预期，调查员失明，在8个美国（US）和2个澳大利亚地点进行了多中心研究。所有符合条件的皮肤病变均为黑色素瘤临床考虑，用ESS设备检查，随后根据皮肤科医生的护理标准进行活检，并进行组织病理学评估。共纳入311名参与者，440个病灶，包括44例黑素瘤（原位63.6％，浸润性36.4％）和44例严重发育不良痣。
■观察到的ESS设备用于黑色素瘤检测的灵敏度为95.5％（95％CI，84.5％至98.8％，44个黑色素瘤中的42个），观察到的特异性为32.5%（95%CI，27.2%至38.3%）。阳性预测值和阴性预测值分别为16.0%和98.1%,分别。
■在高风险人群中对该装置进行了测试，该人群的病变是根据经过董事会认证的皮肤科医生的临床和皮肤镜评估选择进行活检的。大多数登记的病变是色素性的。
■ESS装置检测黑色素瘤的高灵敏度和NPV表明该装置可能是有用的辅助药物，用于黑色素瘤检测的护理点工具。
■研究ESS设备在检测黑色素瘤中的性能。
■预期，调查员失明，在8个美国（US）和2个澳大利亚地点进行了多中心研究。所有符合条件的皮肤病变均为黑色素瘤临床考虑，用ESS设备检查，随后根据皮肤科医生的护理标准进行活检，并进行组织病理学评估。共纳入311名参与者，440个病灶，包括44例黑素瘤（原位63.6％，浸润性36.4％）和44例严重发育不良痣。
■观察到的ESS设备用于黑色素瘤检测的灵敏度为95.5％（95％CI，84.5％至98.8％，44个黑色素瘤中的42个），观察到的特异性为32.5%（95%CI，27.2%至38.3%）。阳性预测值和阴性预测值分别为16.0%和98.1%,分别。
■在高风险人群中对该装置进行了测试，该人群的病变是根据经过董事会认证的皮肤科医生的临床和皮肤镜评估选择进行活检的。大多数登记的病变是色素性的。
■ESS装置检测黑色素瘤的高灵敏度和NPV表明该装置可能是有用的辅助药物，用于黑色素瘤检测的护理点工具。
