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

BACKGROUND

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

OBJECTIVE

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.

METHODS

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.

RESULTS

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).

LIMITATIONS: This was a single-arm trial.

CONCLUSIONS

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.