Can a Handheld Elastic Scattering Spectroscopy Device Aid Primary Care Physicians in Detection and Management of Skin Cancer?

From the 2023 HVPA National Conference

Stephen Merry MD MPH (Mayo Clinic), Elizabeth V. Seiverling MD (UPMC), Thomas Agresta MD MBI, Laura Ferris MD, Brian McCormick MD, Kiran Chatha MD, MPH, Vivien Nguyen PharmD, David Leffell MD, Daniel Siegel MD, Ivana Croghan PhD

Background:
The incidence of skin cancer continues to grow world-wide, therefore early detection and treatment is crucial to prevent associated morbidity. However, primary care physicians (PCPs) have demonstrable difficulty in identifying skin lesions in need of further evaluation. Additionally, access to dermatology specialty care is limited in much of the US. As the most commonly diagnosed malignancy, skin cancer is a major public health concern. Leveraging technology may aid physicians in improving early detection. Elastic scattering spectroscopy (ESS) technology utilizes visual light and detects the backscatter of the light by subcellular structures to differentiate between benign and malignant cells. A handheld ESS device has been developed to aid PCPs in their clinical assessment of concerning skin lesions and better inform referrals to dermatologists.

Objective:
This two-part study aimed: 1. To validate the performance of a handheld ESS device compared to the gold standard of dermatopathology and 2. Evaluate whether device availability improved PCP detection and management of skin cancer.

Methods:
A blinded, prospective, multi-center study clinical validation study was performed at 22 primary care study sites across the US (18) and Australia (4). A total of 1005 patients with 1579 lesions suggestive of skin cancer were enrolled. Lesions were first clinically assessed by PCP investigators and then scanned with the ESS device. Clinical care was provided according to standard of care for suspicious skin lesions. All lesions enrolled were biopsied. Standard of care dermatopathology results were used as the reference standard for assessing device performance. An accompanying utility study included 108 PCP readers evaluating 50 skin lesion cases (25 malignant, 25 benign), a subset that were randomly selected from the validation study to match the breakdown of lesions in the clinical study. PCP readers provided their diagnosis, management decision, and level of confidence with and without device results.

Results:  
Device sensitivity was 95.5% for detecting high-risk lesions, with a specificity of 20.7% compared to 83.0% sensitivity and 54.2% specificity for PCPs for clinically suspicious biopsied lesions. Non-inferiority testing demonstrated that device performance was similar to a performance goal of 90% (published sensitivity of dermatologists) (p<0.0001). In the utility study, both PCP management and diagnostic sensitivity increased significantly (from 82.0% to 91.4% [p=0.0027] and 71.1% to 81.7% [p=0.0085], respectively) with device results, with associated decreases in specificity for diagnosis (60.9% to 54.7%) and referrals (44.2% to 32.4%). Management performance (i.e., Area Under the Curve) increased from 0.684 to 0.729. PCPs reporting high confidence in management decisions increased (36.8% to 53.4%) with device results.

Conclusions:
The ESS device has high sensitivity for detecting skin cancer when compared to gold standard dermatopathology. Additionally, use of the ESS device by PCPs significantly improved diagnostic and management sensitivity, with clinically acceptable decreases in associated specificities. These findings suggest use of the ESS device has the potential to improve PCP skin cancer detection as well as their confidence in skin lesion evaluation and management.

Clinical Implications:
The ESS device can help address a well-established gap in PCP diagnosis and management of skin cancer by providing an additional objective, point-of-care result to improve referral accuracy.

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