%0 Journal Article
%T Multicenter prospective blinded melanoma detection study with a handheld elastic scattering spectroscopy device.
%A Hartman RI
%A Trepanowski N
%A Chang MS
%A Tepedino K
%A Gianacas C
%A McNiff JM
%A Fung M
%A Braghiroli NF
%A Grant-Kels JM
%J JAAD Int
%V 15
%N 0
%D 2024 Jun
%M 38371666
暂无%R 10.1016/j.jdin.2023.10.011
%X <B>UNASSIGNED: </B>The elastic scattering spectroscopy (ESS) device (DermaSensor Inc., Miami, FL) is a noninvasive, painless, adjunctive tool for skin cancer detection.<BR><B>UNASSIGNED: </B>To investigate the performance of the ESS device in the detection of melanoma.<BR><B>UNASSIGNED: </B>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.<BR><B>UNASSIGNED: </B>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.<BR><B>UNASSIGNED: </B>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.<BR><B>UNASSIGNED: </B>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.