BACKGROUND

Case Study: Use of a Multispectral Digital Skin Lesion Analysis Device (MSDSLA) in Pediatrics and Young Adults Marcella Kollmann, MD

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”

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

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.)

I n t r o d u c t i o n

P i v o t a l S t u d y

Baseline Characteristics % (N = 136)

SEX Female 66.2%

Male 33.8%

RACE

Asian or Pacific Highlander 3.7%

White 95.6%

Other 0.7%

AGE

Mean 21

Median 21

Standard Deviation 2.8

FITZPATRICK SKIN TYPE

I 5.1%

II 51.5%

III 36.0%

IV 7.4%

HISTORY OF DYSPLASTIC NEVI* 29.0%

HISTORY OF MELANOMA 7.4%

FAMILY HISTORY OF MELANOMA** 20.2%

BLONDE/RED HAIR 40.4%

BLUE/GREEN EYES 63.2%

NUMBER OF NEVI

1-10 37.5%

11-30 36.8%

31-50 13.2%

> 50 12.5%

USE OF TANNING BED

Never 40.4%

1-10 times 23.5%

11-24 times 14.7%

> 24 times 21.3% *five values were “unknown”; ** twelve values were “unknown”

Table 2. Melanomas from young adults on reader studies

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).

Clinical Dermoscopic Breslow

(mm)

Patient

Age

% of

dermatologists

electing NOT

to biopsy

0.32 24 1.9%

0.17 24 48.6%

0.60 18 57.3%

0.70 17 46.0%

0.28 25 78.1%

0.15 25 76.2%

READER STUDY REVIEW CASE STUDIES – YOUNG ADULTS

17 year old female; regular skin visits

> 50 nevi (none dysplastic)

No family history of melanoma

Fitzpatrick Skin Type II-III

Lesion clinically unsuspicious over 3 yrs

MSDSLA score: 3.5

Pathology: melanoma in situ

MSDSLA

Dermoscopic

Image

Lesion Location

C A S E S T U D Y # 1 : C A S E S T U D Y # 2 :

430 nm 460 nm 500 nm 510 nm 600 nm

660 nm 700 nm 780 nm 880 nm 950 nm

MSDSLA Multispectral Images:

Histology:

24 year old male

Lesion appeared within 4 months of

excision and grew within that time

No risk factors for melanoma

Clinical diagnosis: Spitz/Reed Nevus

MSDSLA score: 3.3

Pathology: melanoma in situ

Lesion Location

MSDSLA

Dermoscopic

Image

Table 1. Characteristics of Young Adults (pivotal study)

430 nm 460 nm 500 nm 510 nm 600 nm

660 nm 700 nm 780 nm 880 nm 950 nm

MSDSLA Multispectral Images:

Histology:

CONCLUSIONS 1 Wong 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.

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.

REFERENCES

Funded in part by a grant from MELA Sciences, Inc.