Page 35 - Noninvasive Diagnostic Techniques for the Detection of Skin Cancers

abstracts found on this topic since 2004, nor were there any studies listed in
ClinicalTrials.gov database.

FDA Status
No information was found on the FDA clearance status for the devices of this type on the
FDA CDRH database for use in the evaluation of skin lesions.

Summary
In this brief, no systematic review or completed controlled trial on ultrasound or color
Doppler technology was found. The available literature addresses the potential benefit of
noninvasive ultrasound imaging of skin lesions as a source of important clinical information to
improve accuracy of diagnosis and assist in pre-operative planning. The evidence accessed for
this study indicated that, while it was first thought that ultrasound alone would be helpful in
differentiating between benign and malignant lesions, research to date supports its use as an
adjunct to other diagnostic tools, but does not provide support for its use as a stand-alone tool.
Additional trials are needed in order to determine the value of ultrasound/color Doppler
techniques in establishing the diagnosis of melanoma or NMSC. Information about training
requirements, or evidence of effectiveness among different patient groups (history,
race/ethnicity) was not identified.

Photodynamic Diagnosis

Photodynamic diagnosis (PDD) of suspicious skin lesions relies on the fluorescent properties
of an exogenous drug or endogenous compound in response to a light source. Topical agents are
used to stimulate the production of endogenous photosensitizers that produce a photodynamic
effect when exposed to light of certain wavelengths and energy.

Available Literature
®
Our systematic literature search on MEDLINE identified a total of 22 abstracts, 16 of which
dealt with PDD for BCC, two for use with suspected melanoma, and four that addressed a
combination of NMSC (n=2) or skin cancer type not specified (n=2) (see Appendix D, Table D2)
These abstracts were reported principally in technical journals, rather than clinical journals.
These abstracts included six primary studies, including one RCT, four comparative cohort
studies and one single case report. The remainder of the studies were narrative reviews (n=9) or
technical reports (n=7) (see Appendix D, Table D1). The single RCT, reported from Sweden,
was designed to evaluate the tolerance threshold of four different application times of 5-
aminolevulinic acid (ALA) in 40 patients (10/group). The endpoint of the study was the
fluorescence intensity between normal skin and tumor tissue. In the remainder of the primary
studies, two reported on lesion characterization and three reported on test accuracy. (see
Appendix D, Table D4). No clinical outcomes were reported.
We identified a single study of photodynamic diagnosis in the ClinicalTrials.gov registry (see
Appendix C, Table C2). This study, not yet open for participant recruitment, is designed to
evaluate the effect of the topical application of ALA on protoporphyrin formation among
patients with NMSC. As noted in the section on confocal microscopy, confocal laser scanning
microscopy will be employed as part of the study outcome assessment.

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