Multicenter prospective blinded melanoma detection study with a handheld elastic scattering spectroscopy device.

Autor:	Hartman RI; Department of Dermatology, Brigham and Women's Hospital, Boston, Massachusetts.; Harvard Medical School, Boston, Massachusetts.; Department of Dermatology, VA Integrated Service Network (VISN-1), Jamaica Plain, Massachusetts., Trepanowski N; Department of Dermatology, Brigham and Women's Hospital, Boston, Massachusetts.; Boston University School of Medicine, Boston, Massachusetts., Chang MS; Department of Dermatology, Brigham and Women's Hospital, Boston, Massachusetts.; Harvard Medical School, Boston, Massachusetts., Tepedino K; North Florida Dermatology, Lake City, Florida., Gianacas C; The George Institute for Global Health, UNSW Sydney, Sydney, Australia.; School of Population Health, UNSW Sydney, Sydney, Australia., McNiff JM; Departments of Dermatology and Pathology, Yale School of Medicine, New Haven, Connecticut., Fung M; University of California Davis School of Medicine, Sacramento, California., Braghiroli NF; Dermatology Department, Miami Cancer Institute, Miami, Florida., Grant-Kels JM; Department of Dermatology, University of Connecticut School of Medicine, Farmington, Connecticut.; Department of Dermatology, University of Florida College of Medicine, Gainesville, Florida.
Jazyk:	angličtina
Zdroj:	JAAD international [JAAD Int] 2023 Nov 15; Vol. 15, pp. 24-31. Date of Electronic Publication: 2023 Nov 15 (Print Publication: 2024).
DOI:	10.1016/j.jdin.2023.10.011
Abstrakt:	Background: The elastic scattering spectroscopy (ESS) device (DermaSensor Inc., Miami, FL) is a noninvasive, painless, adjunctive tool for skin cancer detection. Objectives: To investigate the performance of the ESS device in the detection of melanoma. Methods: 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. Results: 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. Limitations: 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. Conclusion: 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. Competing Interests: Drs Tepedino, McNiff, Fung, and Hartman were all provided funding for their participation in the study. Mr Gianacas is a paid consultant for DermaSensor, Inc. Dr Grant-Kels is an uncompensated member of the Advisory Board for DermaSensor, Inc.
Databáze:	MEDLINE
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