Elastic Scattering Spectroscopy on Patient-Selected Lesions Concerning for Skin Cancer

Area of Science:

• Dermatology
• Medical Devices
• Oncology

Background:

• Limited dermatologist access necessitates primary care clinician (PCC) involvement in early skin cancer detection.
• A handheld elastic scattering spectroscopy (ESS) device was developed to assist PCCs in skin lesion assessment.

Purpose of the Study:

• To evaluate the diagnostic performance of a handheld ESS device used by PCCs for skin lesion assessment.
• To compare the diagnostic accuracy of PCCs with and without the ESS device.

Main Methods:

• Prospective study involving 3 PCCs evaluating 178 skin lesions using a handheld ESS device.
• Comparison against pathology results or a 3-dermatologist panel.
• Analysis of sensitivity, specificity, NPV, PPV, and AUC.

Main Results:

• The ESS device achieved 90.0% sensitivity and 60.7% specificity, significantly outperforming PCCs without the device (40.0% sensitivity, 84.8% specificity).
• Device NPV was 98.9%, and AUC was 0.815 compared to 0.643 for PCCs alone.
• The device showed 88.2% concordance with dermatologist panel recommendations for referral.

Conclusions:

• The ESS device improves diagnostic and management sensitivity for malignant skin lesions when used by PCCs.
• This technology aids in classifying benign lesions, potentially increasing skin cancer detection rates.
• Implementation of the ESS device may enhance access to specialist dermatological care.