Page 25 - Noninvasive Diagnostic Techniques for the Detection of Skin Cancers

FDA Status
The cameras used during total body photography are not considered medical devices. They
are therefore not regulated by the FDA. Similarly, the imaging systems used to store, analyze,
and transmit images are not under the FDA purview.

Summary
Overall, photography included 7 abstracts from 6 unique RCTs—accounting for 64 percent
of all RCTs included in this technical brief (Appendix D, Table D1). The RCTs evaluated
outcomes including diagnostic accuracy, excision rates, patient satisfaction, cost savings and
treatment adherence and followup (Appendix D, Table D1). Outcomes were measured at both
the patient level (5 trials) and provider level (2 trials), with study participant numbers ranging
from 88 to 5784. Almost all of the trials were conducted in a primary care setting (2 in the
United States); only one was set in dermatology. Four of the RCTs were conducted outside of the
U.S.: 3 in Australia, 1 in the United Kingdom. Abstracts from non-randomized studies consisted
of mostly comparative and non-comparative cohorts (47 percent)—the remaining abstracts
included review articles and data from diagnostic test studies. We found that the use of
photography to capture suspicious skin lesions of the entire body for monitoring purposes is
commonly used in dermatology practices, but not typically in a primary care setting.
Photographic surveillance is recommended for patients at high risk of skin cancer, based on
family history, history of dysplastic nevi, or history of prior malignant lesions. 48,49 However, the
age of onset and frequency at which it should be performed is unclear. The affordability and
adaptability of digital imaging permit the increased ease of electronic image storage and allow
for side-by-side comparisons at future visits. The evolution of computerized imaging systems has
also enhanced the ability to convey these lesions from patients to providers and across provider
types. The available data are limited on the role of photography in changing clinical outcomes,
including confirmation that baseline photographs in specialty clinics improve the detection of
melanoma, resulting in detection of earlier stage lesions or recurrent lesions. While there are
some studies, principally from Australia, addressing the impact of photography in primary care
settings, no similar studies have been conducted in the U.S. Furthermore, data are limited on the
role of photography for specific racial/ethnic groups. No current trials on photography were
found in ClinicalTrials.gov.

Dermoscopy

Dermoscopy shows subsurface structures of the skin with the use of handheld devices that
extend optical light ray penetration beyond the skin surface and minimize surface reflection. In
contrast, naked eye examination limits visualization of certain skin structures because the
stratum corneum has reflective properties.

Available Literature
The majority of the included abstracts addressed dermoscopy (69 percent) (see Appendix D,
Table D1). Our search identified 433 abstracts on dermoscopy from the following types of
studies: 3 trials, 39 comparative cohort studies; 96 noncomparative cohort studies/case series; 52
diagnostic test reviews/studies; 49 case reports; 78 narrative reviews; 5 systematic reviews; 74
technical reports; 37 guidelines, opinion pieces, or commentaries, and others. Of these, 324
abstracts provided information on the type of malignancy studied; 238 on melanoma, 22 on

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