In vivo molecular skin fluorescence imaging for noninvasive assessment of atypical nevi and melanoma: A validation trial

TL;DR

This study tests a noninvasive imaging technique to distinguish between benign and malignant skin lesions, potentially reducing the need for biopsies.

Contribution

The study introduces and validates skin fluorescent imaging (SFI) for detecting αvβ3 integrin in melanocytic lesions.

Findings

SFI showed 93% sensitivity and 77% specificity using a cutoff score of 5 for lesion discrimination.

A cutoff score of 7 achieved 87% sensitivity and 91% specificity for high-risk lesion detection.

The area under the ROC curve was 0.907, indicating strong diagnostic performance.

Abstract

Current visual assessments and assistive technologies for melanoma detection primarily focus on detecting morphological changes, often requiring invasive biopsies for confirmation.

To determine the efficacy of skin fluorescent imaging (SFI), a novel noninvasive technology for detection of αvβ3 integrin in the tumor microenvironment, for discrimination of benign from malignant melanocytic lesions.

A prospective validation trial evaluated 240 clinically suspicious cutaneous pigmented lesions prior to biopsy in 6 academic and community dermatology clinics in California, Utah, and Oregon.

The distribution of lesions included 99 (41%) lesions without dysplasia, 59 (25%) nevi with low-grade dysplasia, 51 (21%) nevi with high-grade dysplasia, 20 (8.3%) melanoma in situ, and 11 invasive melanomas (4.6%). SFI cutoff scores of 5 and 7 demonstrated sensitivities of 93% and 87% and specificities of 77% and 91%, respectively, for discrimination of lesions with no or low-grade dysplasia from those with high-grade dysplasia or melanomas. The area under the receiver operating characteristic curve was 0.907 (95% CI 0.864-0.951, P <.0001).

This was a single-arm trial.

SFI demonstrated high sensitivity and specificity for discriminating low-risk from high-risk lesions, representing a promising approach to enhance evaluation of clinically concerning pigmented lesions and reduce unnecessary biopsies.

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