Page 19 - Noninvasive Diagnostic Techniques for the Detection of Skin Cancers

Table 1. Data availability to address the elements of the guiding questions for the different diagnostic technologies
Modalities in general
clinical use Modalities in limited clinical use Investigational

Photography Dermoscopy Confocal Microscopy Ultrasound/ Laser Doppler PDD Multiphoton Laser Scanning Microscopy Electrical Bio- Impedance OCT Tape Stripping Multispectral imaging Thermography

GQ1: What are the techniques?
a. Type of techniques/modalities           
b. Postulated advantages and           
disadvantages?
c. Potential safety issues and harms? nd  nd   nd nd nd nd nd nd
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d. FDA status ?           
e. Training and certifications?   nd nd nd nd nd nd nd nd nd
f. Newer techniques in development?   nd   nd nd  nd nd 
GQ2: Clinical context: setting, which cancers, which patients?
a. Setting where the
technique/modality was used     nd nd nd  nd  nd
b. Suspect different effectiveness for          NA 
different cancer types?
c. Suspect different effectiveness for    
patients with different histories? nd nd nd nd nd nd nd
d. Suspect different effectiveness for nd  nd nd  nd nd nd nd nd nd
different race/ethnicity?
GQ3: What published and unpublished studies? Synthesis of:
a. Indication/patient inclusion criteria           
2
b. Study design and size           nd
c. Role of the test in patient           
management
d. Outcomes assessed           
e. Comparators used      nd nd  nd  nd
f. Length of follow-up nd  nd  nd nd  nd nd nd nd

1 FDA status is addressed for each diagnostic modality regardless of the presence of clearance status information on the FDA CDRH database.
2 No primary studies on Thermography were identified.

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