1. Melanoma incidence is rising in young adults aged 16-25, making early detection in this population challenging. 2. A multispectral digital skin lesion analysis device (MSDSLA) was helpful in detecting early melanomas in two case studies of young patients, correctly identifying melanomas that were initially unsuspicious. 3. In clinical studies, the MSDSLA demonstrated high sensitivity in detecting melanoma in young adults, including one melanoma in situ and invasive melanomas with a median thickness of 0.50mm, suggesting it can assist dermatologists in evaluating lesions in this age group.

1. Case Study: Use of a Multispectral Digital Skin Lesion Analysis Device (MSDSLA) in Pediatrics and Young Adults
Marcella Kollmann, MD
BACKGROUND
C A S E S T U D I E S – Y O U N G A D U LT S
READER STUDY REVIEW
Introduction
 Differentiation of early melanomas from benign lesions in young adults
(16 – 25) can be difficult clinically
 Incidence of melanoma in children and adolescents has increased at an
annual rate of 2.0% per year from 1973 to 20091
 Biopsy ratio of up to 80 to 1 have been observed in younger patients2
 Melanoma is the most common cancer in young adults aged 20 to 303
 MSDSLA can be used to help dermatologists decide which lesions may
be suspicious for melanoma by providing information about the structure
of a lesion from under the skin (MelaFind; MELA Sciences, Inc.)
 Two reader studies were conducted presenting high resolution images
and case histories for 130 pigmented skin lesions to dermatologists in
the U.S. (n = 110)5 and in Germany5 (n = 101). After reviewing the
case, dermatologists were asked to provide their lesion management
decisions.
 Sensitivity of both U.S. and German dermatologists were 72% and
70%, respectively.
 5 melanomas from young adult patients, all invasive, were randomly
selected for review by these 211 dermatologists (Table 1).
Table 2. Melanomas from young adults on reader studies
Pivotal Study
 The pivotal study for MSDSLA (MelaFind®: Irvington, NY) established
that it was a safe and effective device by demonstrating high sensitivity to
melanoma (98.3%) and better specificity than study clinicians (9.9% vs.
3.7%, p = 0.02)4
 In the pivotal study, 183 lesions from young adult patients aged 16 to 25
were enrolled; of these, 13 were melanomas or high grade lesions, 11 of
which were correctly considered MSDSLA “High Disorganization”
Clinical
Dermoscopic
% of
Breslow Patient dermatologists
(mm)
Age
electing NOT
to biopsy
MSDSLA
Dermoscopic
Image
CASE STUDY # 1:
 17 year old female; regular skin visits
CASE STUDY # 2:
 24 year old male
 Lesion appeared within 4 months of
excision and grew within that time
 > 50 nevi (none dysplastic)
 No family history of melanoma
 Fitzpatrick Skin Type II-III
Lesion Location
 No risk factors for melanoma
 Clinical diagnosis: Spitz/Reed Nevus
 Lesion clinically unsuspicious over 3 yrs
MSDSLA
Dermoscopic
Image
Lesion Location
 MSDSLA score: 3.3
 MSDSLA score: 3.5
 Pathology: melanoma in situ
 Pathology: melanoma in situ
MSDSLA Multispectral Images:
MSDSLA Multispectral Images:
430 nm
24
500 nm
510 nm
600 nm
430 nm
460 nm
500 nm
510 nm
600 nm
660 nm
0.32
460 nm
700 nm
780 nm
880 nm
950 nm
660 nm
700 nm
780 nm
880 nm
950 nm
1.9%
 Of the 11 melanomas enrolled from young adults, all were invasive,
except one melanoma in situ, with median Breslow thickness of 0.50 mm
 A total of 136 young adults were enrolled on the pivotal study; none had a
history of pigmented basal or squamous cell carcinoma. Table 1 shows
characteristics of these young adults
0.17
24
48.6%
0.60
18
57.3%
0.70
17
46.0%
Histology:
Histology:
Table 1. Characteristics of Young Adults (pivotal study)
Baseline Characteristics
Female
Male
Asian or Pacific Highlander
RACE
White
Other
Mean
AGE
Median
Standard Deviation
I
II
FITZPATRICK SKIN TYPE
III
IV
HISTORY OF DYSPLASTIC NEVI*
HISTORY OF MELANOMA
FAMILY HISTORY OF MELANOMA**
BLONDE/RED HAIR
BLUE/GREEN EYES
1-10
11-30
NUMBER OF NEVI
31-50
> 50
Never
1-10 times
USE OF TANNING BED
11-24 times
> 24 times
SEX
% (N = 136)
66.2%
33.8%
3.7%
95.6%
0.7%
21
21
2.8
5.1%
51.5%
36.0%
7.4%
29.0%
7.4%
20.2%
40.4%
63.2%
37.5%
36.8%
13.2%
12.5%
40.4%
23.5%
14.7%
21.3%
CONCLUSIONS
REFERENCES
1 Wong
0.28
25
78.1%
1. Melanomas on young adult patients can be difficult
to detect.
2. MSDSLA can be helpful in assisting in the detection
of early melanomas within young adults, a
population where melanoma incidence is on the rise.
0.15
25
76.2%
JR. Pediatrics. 2013;doi:10.1542/peds.2012-2520
2 English et al. Med J Aust. 2004
3 Masci P, Borden EC. Malignant Melanoma: Treatments Emerging, but early detection is still
key. Cleveland Clinic Journal of Medicine July 2002; Vo. 69 # 7: 529-545.
4
Monheit G, Cognetta AB, Ferris L, et al. The performance of MelaFind: a prospective
multicenter study. Arch Dermatol. 2011;147:188-94.
5 Chen SC, Wells R and Adrian J. (2011, February). Performance of an adjuvant melanoma
detection tool compared to physicians. Poster presented at the American Academy of
Dermatology, New Orleans, LA.
6
Hauschild, Axel. Protocol 20101: To Excise or Not?: Comparing Clinical Management
Decisions for Melanoma Between Dermatologists with and without the Aid of MelaFind.
University of Kiel, Kiel, Germany. Unpublished data; August 2012.
*five values were “unknown”; ** twelve values were “unknown”
Funded in part by a grant from MELA Sciences, Inc.