Multicenter prospective blinded melanoma detection study with a handheld elastic scattering spectroscopy deviceCapsule Summary

Rebecca I. Hartman, MD, MPH; Nicole Trepanowski, MD; Michael S. Chang, MD; Kelly Tepedino, MD; Christopher Gianacas, MBiostat; Jennifer M. McNiff, MD; Maxwell Fung, MD; Naiara Fraga Braghiroli, MD, PhD; Jane M. Grant-Kels, MD

JAAD International (Jun 2024)

Multicenter prospective blinded melanoma detection study with a handheld elastic scattering spectroscopy deviceCapsule Summary

Rebecca I. Hartman, MD, MPH,
Nicole Trepanowski, MD,
Michael S. Chang, MD,
Kelly Tepedino, MD,
Christopher Gianacas, MBiostat,
Jennifer M. McNiff, MD,
Maxwell Fung, MD,
Naiara Fraga Braghiroli, MD, PhD,
Jane M. Grant-Kels, MD

Affiliations

Rebecca I. Hartman, MD, MPH: 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; Correspondence to: Rebecca I. Hartman, MD, MPH, Department of Dermatology, Brigham and Women’s Hospital, 221 Longwood Ave, Boston, MA 02115.
Nicole Trepanowski, MD: Department of Dermatology, Brigham and Women’s Hospital, Boston, Massachusetts; Boston University School of Medicine, Boston, Massachusetts
Michael S. Chang, MD: Department of Dermatology, Brigham and Women’s Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts
Kelly Tepedino, MD: North Florida Dermatology, Lake City, Florida
Christopher Gianacas, MBiostat: The George Institute for Global Health, UNSW Sydney, Sydney, Australia; School of Population Health, UNSW Sydney, Sydney, Australia
Jennifer M. McNiff, MD: Departments of Dermatology and Pathology, Yale School of Medicine, New Haven, Connecticut
Maxwell Fung, MD: University of California Davis School of Medicine, Sacramento, California
Naiara Fraga Braghiroli, MD, PhD: Dermatology Department, Miami Cancer Institute, Miami, Florida
Jane M. Grant-Kels, MD: Department of Dermatology, University of Connecticut School of Medicine, Farmington, Connecticut; Department of Dermatology, University of Florida College of Medicine, Gainesville, Florida

Journal volume & issue: Vol. 15
pp. 24 – 31

Abstract

Read online

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.

Published in JAAD International

ISSN: 2666-3287 (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Dermatology
Website: https://www.journals.elsevier.com/jaad-international

About the journal

Abstract

Keywords