Optical Transfer Diagnosis Differentiating Benign and Malignant Pigmented Lesions in a Simulated Primary Care Practice

Abstract

Background

The detection of melanoma poses a substantial challenge, particularly for primary care providers (PCPs) who may have limited training in discriminating between suspicious and benign melanocytic lesions. The noninvasive optical transfer diagnosis (OTD) method was designed to be used by PCPs in their decision-making process.

Objectives

The aim of this clinical study was to assess the potential of the OTD method by developing, training, and validating an OTD indication algorithm for automated discrimination between benign melanocytic lesions and malignant lesions, based on a set of 712 lesions.

Methods

The authors performed in vivo OTD capture and subsequent analysis of 712 pigmented lesions. Of the lesions, 415 were clinically and dermoscopically benign, and 297 were dermoscopically suspicious or equivocal. After image capture, all suspicious or equivocal lesions were biopsied and examined histopathologically.

Results

Of the 297 suspicious or equivocal lesions, histopathologic findings revealed 80 to be malignant (64 melanomas, 13 basal cell carcinomas, and 3 squamous cell carcinomas). OTD misdiagnosed 1 of the 80 malignant lesions as benign (sensitivity, 99%). The OTD specificity was 93% for the dermoscopically benign lesions, 73% for all lesions included in the study, and 36% for the clinically suspicious, but histopathologically benign lesions.

Conclusions

High sensitivity and specificity, as provided by OTD in this preliminary study, would help PCPs reduce the number of referrals for dermatology consultation, excision, or biopsy. Further studies are planned for screening patients in a primary care setting, with comparisons of OTD results to biopsy or dermoscopy results.

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