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

Summary

In a multicenter prospective validation of 240 pigmented lesions, skin fluorescence imaging targeting αvβ3 integrin achieved sensitivities of 93% and 87% and specificities of 77% and 91% at score cutoffs of 5 and 7, respectively (AUC 0.907). SFI effectively discriminated low-risk from high-risk lesions and may reduce unnecessary biopsies.

Key Findings

• Prospective, multicenter validation on 240 lesions prior to biopsy
• At SFI cutoff 5: sensitivity 93%, specificity 77%; at cutoff 7: sensitivity 87%, specificity 91%
• AUC of ROC was 0.907 (95% CI 0.864–0.951)
• Lesion distribution included 99 without dysplasia, 110 dysplastic nevi (low/high grade), and 31 melanomas (in situ/invasive)

Clinical Implications

SFI can be incorporated as an adjunct triage tool to identify high-risk melanocytic lesions for biopsy while safely deferring low-risk lesions, potentially reducing patient morbidity and healthcare costs.

Limitations

• Single-arm validation without comparator devices
• Generalizability beyond participating clinics and across skin phototypes requires further study

Future Directions

Conduct head-to-head trials versus dermoscopy/other assistive tools, assess performance across Fitzpatrick types, and evaluate impact on biopsy rates and cost-effectiveness in real-world pathways.