• PCP device use resulted in a significant improvement in
  both management and diagnostic sensitivity compared to
  standard of care alone; physician false negative referrals
  decreased by half, from 18.0% to 8.6%
• PCPs’ AUROC was 0.762 when aided by the device and was 0.708 with standard of care alone
• Nearly all (99%) of PCP participants reported the device would provide at least one benefit, including:
  • “Detecting more skin cancer” (82%)
  • “Providing you with greater confidence in your clinical assessments and management decisions” (81%)
  • “Helping you to prioritize the risk level of concerning lesions to prioritize patient management, e.g. a prioritized dermatology referral” (72%)
  • Increasing your frequency of assessing patients for skin cancer” (63%)

Materials & Methods

The handheld ESS device measures spectra of skin lesions and uses Convolutional Neural Networks to classify the lesion’s scanned properties against those of known malignant and benign lesions. The output of the ESS classifier is “Investigate Further” or “Monitor”. Additionally, for “Investigate Further” classified lesions, a score from 1 to 10 is provided which corresponds to the amount of spectral similarity a lesion has to malignant lesions in studies, with 10 representing the highest amount.

The algorithm was trained and validated with over 11,000 spectral scans from over 3,500 skin lesions, including histologically confirmed melanoma and non melanoma skin cancer (NMSC); as well as biopsied and unbiopsied benign lesions, as diagnosed by board-certified dermatologists [6,7]. The device is intended to act as an adjunctive tool for lesions that are suspicious of melanoma or NMSC.

This study consisted of ten dermatology study centers scanning lesions that they found concerning for melanoma. All dermatologists were blinded to the device results. Gold-standard comparison for performance of the device and dermatologists was the biopsy result with multiple dermatopathologist review when consensus was not reached during the primary review process. High resolution digital images and the patient’s clinical information, including prior skin cancer history, risk factors and physical examination results, were recorded for each case. After clinical evaluation, dermatologists reported their diagnosis and confidence level, which provided the physician comparison data. The results evaluated were sensitivity, specificity, Negative Predictive Value (NPV, and Positive Predictive Value (PPV) for melanoma, melanoma + severely atypical nevi, and all high-risk lesions. Area Under the Curve (AUC) was also calculated and modelled and compared between the study dermatologists and the device performance.

Results

A total of 311 patients with 440 biopsied lesions were evaluated by the study dermatologists, device and dermatopathology results. Most patients were male (54%), white (98%) and non-Hispanic (96%) and Fitzpatrick skin type II (53%) or III (20%). Lesions were most commonly described as flat (84%), pigmented (96%) and with a median length of 5mm.

Discussion and Conclusion

The use of the handheld ESS device by physicians, in addition to clinical evaluation, may improve melanoma detection. The device was able to identify 96% of melanomas when compared to dermatopathology results. In addition, the high NPV of ~98% can provide confidence in ruling out melanoma. When presented with a high score (8-10), the PPV was 47% for melanoma which equates to a NNB of 2, meaning approximately 50% of scores 8-10 may be melanoma.

The high concordance of the handheld device with dermatopathology may help alleviate patient and dermatologist concern for benign lesions mimicking melanoma, particularly for nevi that do not merit re-excision.

When compared to other tools and the current gold-standard available for visually assessing skin lesions (i.e. ABCDEs), the ESS device has AUC similar to dermatologists, high sensitivity for malignancy, and reasonable specificity for ruling out suspicious yet benign lesions biopsied by dermatologists, thereby providing important objective information to providers. While this study was conducted by melanoma specialists, given the device’s similar overall performance to these specialists and its simple, non-invasive use, there is potential for the device to be used to help rule in or out lesion referrals for primary care physicians.

References

1. Cancer Facts and Figures 2021. American Cancer Society. https:// www.cancer.org/content/dam/cancer-org/research/cancer-facts-andstatistics/annual-cancer-facts-and-figures/2021/cancer-facts-andfigures-2021.pdf. Accessed January 13, 2021.
2. Skin Cancer Statistics 2021. World Cancer Research Fund. https:// www.wcrf.org/dietandcancer/skin-cancer-statistics/Accessed September 1, 2021.
3. Mohan SV, Chang AL. Advanced basal cell carcinoma: epidemiology and therapeutic innovations. Current dermatology reports. 2014 Mar 1;3(1):40- 5.
4. Fahradyan, A., Howell, A. C., Wolfswinkel, E. M., Tsuha, M., Sheth, P., & Wong, A. K. (2017, December). Updates on the management of nonmelanoma skin cancer (NMSC). In Healthcare (Vol.
5. Rodriguez-Diaz E, et al. Optical Spectroscopy as a Method for Skin Cancer Risk Assessment. Photochem Photobiol. 2019;95(6):1441-1445.
6. Benvenuto-Andrade C, Manolakos D, Cognetta AB. Safety and Effectiveness of Elastic Scattering Spectroscopy and Machine Learning in the Evaluation of Skin Lesions. Poster Presentation, World Congress of Teledermatology, Nov 2020
7. Manolakos, D. Rabinovitz, H. Geisse J, Bonning M. Rodriguez-Diaz, E. Bigio I. Cognetta, A. Clinical Validation of a Handheld Elastic Scattering Spectroscopy- Artificial Intelligence Device. Podium Presentation at AAD Innovations Academy, Jul 21-24th 2022.
8. Tepedino M., Balthazar D., Hucks, C., Zeitouni, N. Use of Elastic-scattering spectroscopy on Patient-Selected Lesions that are Concerning for Skin Cancer. Poster Presentation at American Dermoscopy Meeting, Jun 29- Jul 2, 2022

Disclosures

This study was supported by a grant from DermaSensor Inc.

Materials & Methods

The handheld ESS device (Figure 1) measures spectra of skin lesions and uses an algorithm to classify the lesion’s scanned properties against those of known malignant and benign lesions, providing an output of “Investigate Further” or “Monitor”, respectively. Additionally, for “Investigate Further” classified lesions, a score from 1 to 10 is provided which corresponds to the degree of spectral similarity a lesion has to malignant lesions in studies, with 10 representing the highest degree.

The algorithm has been trained and validated with over 20,000 spectral scans from over 4,500 skin lesions, including histologically confirmed melanoma, BCC, SCC and benign lesions as well as unbiopsied benign lesions diagnosed by board-certified dermatologists.

An accompanying clinical validation study was performed in which 1579 lesions from 1005 patients were assessed with the ESS device [6].

In this clinical utility study, 108 PCPs evaluated 50 skin lesions (25 malignant, 25 benign), with and without ESS device output. For each case, high resolution digital clinical images (Figure 2A and 2B), the patient’s clinical information, including prior skin cancer history, risk factors, and physical examination results were provided. The PCPs completed a questionnaire about their diagnosis of the lesion, their recommended management decision and their confidence level on their management decision for each case.

Sensitivity and specificity of PCP diagnostic and management with and without the device output were calculated.

PCP Participants

PCP participants (Table 1) included U.S. board-certified internal and family medicine physicians with an even distribution of years in practice (range: 1-21+ years). PCPs were recruited from across the U.S., including urban and rural areas.

Lesion Characteristics

The 50 lesions (Table 2) evaluated by PCPs were dispersed across the body (22.0% head, 26.0% upper and 10.0% lower extremities, 32.0% trunk) had a mixture of surfaces (66.0% elevated vs. 34.0% flat), textures (46.0% smooth vs. 54.0% rough), and pigmentation (48.0% light vs. 52% dark). Pathology of lesions were matched to the clinical study prevalence.

Results

Management sensitivity increased significantly from 82.0% to 91.4% (p=0.003) with device output (Table 3). Diagnostic sensitivity increased significantly from 71.1% to 81.7% with device output (p=0.008) (Table 4).

Conclusion

Use of the ESS device by PCPs significantly improved both diagnostic sensitivity (from 71% to 82%) and management sensitivity (from 82% to 91%). There were clinically acceptable decreases in associated specificities. Additionally, the effectiveness analyses observed an increase in PCPs’ overall diagnostic performance (i.e. AUC) and confidence level in their management decisions with the use of the handheld ESS device. The findings suggest the use of the ESS device output improves PCP skin cancer detection and confidence in skin lesion evaluation and management.

References

1. Hester T, Thomas R, Cederna, J. et al. Increasing Access to Specialized Dermatology Care: A Retrospective Study Investigating Clinical Operation and Impact of a University-Affiliated ree Clinic. Dermatol Ther (Heidelb). 2021;11(1):105-115.)
2. Perera E, Gnaneswaran N, Jennens R, Sinclair R. Malignant Melanoma. Healthcare (Basel). 2013;2(1):1- 19.
3. Rodriguez-Diaz E, et al. Optical Spectroscopy as a Method for Skin Cancer Risk Assessment. Photochem Photobiol. 2019;95(6):1441-1445.
4. Thames T et al. Clinical Utility of a Handheld Elastic Scattering Spectroscopy Tool and Machine Learning on the Diagnosis and Management of Skin Cancer. Poster Presentation, STFM Annual Spring Conference, April 30-May 4, 2022.
5. Hartman R, Tepedino K, Fung, MA, McNiff, JM, Patrick G, Nguyen V, Chatha K, Grant-Kels J. Validation of a Handheld Elastic-scattering Spectroscopy Device on Lesions Suggestive of Melanoma. J Dermatol Physician Assist. 2022 Fall; 16(4):51.
6. Merry SP, McCormick, B, Leffell D, Chatha K, Croghan I. Clinical Performance of Novel Elastic Scattering Spectroscopy (ESS) in Detection of Skin Cancer: A Blinded, Prospective, Multi-Center Clinical Trial [Initial Results]. Poster Presentation, Innovations in Dermatology, Las Vegas NV, Nov 3-6, 2022.
7. Clinical Performance of Novel Elastic Scattering Spectroscopy (ESS) in Detection of Skin Cancer: A Blinded, Prospective, Multi-Center Clinical Trial [Initial Results]. Poster Presentation, Innovations in Dermatology, Las Vegas NV, Nov 3-6, 2022.

Disclosures

This study was supported by a grant from DermaSensor Inc. Drs. Nguyen and Chatha are employees of DermaSensor, Inc.

Adapted from Seiverling EV, Agresta T, Cyr P, Caines L, Nguyen VL, Chatha K, Siegel DM. Clinical Utility of an Elastic Scattering Spectroscopy Device in Assisting Primary Care Physician’s Detection of Skin Cancers. Poster Presentation, Maui Derm Hawaii Conference, Wailea, HI, January 24-28, 2023.