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

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Figure 1.
Handheld Elastic Scattering Spectroscopy Created by DermaSensor, Inc.

Table 1.

Description of Patient Characteristics (Based on Investigators Assessment)

Characteristics	n = 155
Gender
Man	56 (36.1%)
Woman	99 (63.9%)
Age (years)
Mean (SD)	65.6 (14.3)
Median (Q1; Q3)	69.0 (58.5; 76.0)
Ethnicity
Hispanic or Latino	9 (5.8%)
Not Hispanic or Latino	146 (94.2%)
Race
White	143 (92.2%)
Native Hawaiian or Other Pacific Islander	1 (0.7%)
Black or African American	11 (7.1%)
Fitzpatrick skin type
I - Always burns, never tans	20 (12.9%)
II - Always burns, tans minimally	32 (20.7%)
III - Sometimes mild burn, tans uniformly	27 (17.4%)
IV - Burns minimally, always tans well	23 (14.8%)
V - Very rarely burns, tans very easily	42 (27.1%)
VI - Never burns	11 (7.1%)
Risk Factors
New or changing lesion(s)	142 (91.6%)
Personal history of skin cancer	56 (36.1%)
Family history of skin cancer	26 (16.8%)
Fair Skin/Freckling/Light Hair	21 (13.5%)
Ultraviolet light exposure (natural or tanning bed)	6 (3.9%)
Many moles and/or dysplastic nevi	4 (2.6%)
None of the above	1 (0.6%)

Table 2.

Clinical Assessment of Lesions by Primary Care Clinicians (PCC) Investigators

Clinical Diagnosis	n = 177
Benign	155/177 (87.6%)
Malignant	22/177 (12.4%)
Level of Confidence
High	160/177 (90.4%)
Low	17/177 (9.6%)
Malignant Diagnoses
BCC (Basal Cell Carcinoma)	9/22 (40.9%)
SCC (Squamous Cell Carcinoma)	8/22 (36.4%)
Melanoma	5/22 (22.7%)
Benign Diagnoses
Seborrheic Keratosis	51/155 (32.9%)
Solar Lentigo	31/155 (20.0%)
Actinic Keratosis	17/155 (11.0%)
Mildly atypical melanocytic nevus	12/155 (7.7%)
Benign other	10/155 (6.5%)
Simple Lentigo	7/155 (4.5%)
Dermatofibroma	7/155 (4.5%)
Angioma or vascular lesion	6/155 (3.9%)
Senile Purpure	2/155 (1.3%)
Sebaceous hyperplasia	2/155 (1.3%)
Moderately atypical melanocytic nevus	2/155 (1.3%)
Epidermal cyst	2/155 (1.3%)
Benign melanocytic nevus	2/155 (1.3%)
Verruca	1/155 (0.6%)
Spitz Nevus	1/155 (0.6%)
Blue nevus	1/155 (0.6%)
Acrochordon	1/155 (0.6%)
Decision Regarding Further Evaluation
Not concerned	150/177 (84.7%)
Biopsy	26/177 (14.7%)
Refer to Dermatologist	1/177 (0.6%)

Table 3.

Concordance Between Device and Reference Standard: Diagnosis

	Reference: biopsy¹or panel consensus²
Device Decision	Benign	Malignant	All
Benign	88/145 (60.7%)	1/10 (10.0%)	89/155 (57.4%)
Malignant	57/145 (39.3%)	9/10 (90.0%)	66/155 (42.6%)
Specificity (95% CI)	0.61 (0.53 - 0.68)
Sensitivity (95% CI)*	0.90 (0.71 - 1.00)
NPV (95% CI)	0.99 (0.93 - 0.99)
PPV (95% CI)	0.14 (0.07 - 0.25)
	Reference: panel consensus² alone
Benign	85/136 (62.5%)	1/12 (8.3%)	86/148 (58.1%)
Malignant	51/136 (37.5%)	11/12 (91.7%)	62/148 (41.9%)
Specificity (95% CI)	0.63 (0.54 - 0.70)
Sensitivity (95% CI)*	0.92 (0.76 - 1.000)
NPV (95% CI)	0.99 (0.93 - 0.99)
PPV (95% CI)	0.18 (0.09 - 0.30)

Notes: ¹Biopsy results are used as reference standard in lieu of consensus dermatologist panel assessment when biopsy results are available. Biopsy results are available for 22 lesions. ²Panel consensus: only includes diagnosis where all panel members agreed, regardless of the number of members in the panel. Panel consensus was available for 148 lesions. 95% Confidence interval (CI) calculated accounting for the within-subject correlation using the Wilson method *Wilson method not estimable, Wald method used.

Table 4.

Concordance Between Device and Panel: Management Decision

	Panel Decision to Further Evaluate
Device Decision to Further Evaluate	No	Yes	All
	Reference: panel consensus¹
No	57/81 (70.4%)	2/17 (11.8%)	59/98 (60.2%)
Yes	24/81 (29.6%)	15/17 (88.2%)	39/98 (39.8%)
Specificity (95% CI)	0.70 (0.60–0.79)
Sensitivity (95% CI)	0.88 (0.64–0.97)
NPV (95% CI)	0.97 (0.88–0.99)
PPV (95% CI)	0.39 (0.24–0.55)

Notes: ¹Panel consensus: only includes decision where all panel members agreed, regardless of the number of members in the panel. Panel consensus for management decision was available for 98 lesions only. Those without consensus were excluded from this analysis. 95% Confidence interval (CI) calculated accounting for the within-subject correlation using the Wilson method.
Abbreviations: NPV, negative predictive value; PPV, positive predictive value.

Table 5.

Device to Primary Care Clinicians (PCC) Comparison