An observational study in Non-melanocytic Skin Tumors and Melanocytic Skin Tumors, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-09-07.
Sponsored by Medical University of Vienna · Observational
In vivo differentiation of benign and malignant skin lesions is a fundamental issue in clinical dermatology. Malignant skin diseases are known to be accompanied by structural alterations. Conventional excisional biopsies and further histopathology are regarded as the reference standard for investigating these pathologies. Biopsies are invasive procedures and additionally may cause side effects. Therefore, research efforts are focused on the development of diagnostic techniques capable of providing in vivo information on the skin's structure. Optical coherence tomography (OCT) is a technical application, which allows the identification of microscopic patterns indicative for benign and malignant skin lesions. OCT is a promising noninvasive imaging technique for the micromorphology of the skin. So far, it's clinical application, as an additional diagnostic tool for malignant skin lesions has been studied in a limited extend. To evaluate the clinical usefulness of OCT, we conducted a prospective pilot study at the Department of Dermatology, Medical University of Vienna. The study is in cooperation with the Center of Biomedical Engineering and Physics at the Medical University of Vienna.
A total of 70 malignant skin lesions was evaluated during this prospective pilot study. Diagnoses based on OCT imaging as an additional diagnostic tool, were compared to those based on the clinical standard pathway at the Department of Dermatology, Medical University of Vienna. For the purpose of this study, the histopathological diagnosis was used as the reference diagnostic standard.
The major aims of this study is the investigation of the ability of ultrahigh resolution OCT to identify fine morphological characteristics associated with basal cell carcinoma, actinic keratosis, superficial squamous cell carcinoma, seborrheic keratosis, melanocytic nevi and melanoma.
Optical coherence tomography (OCT) is a technical application, which allows the identification of microscopic patterns indicative for benign and malignant skin lesions. It is a promising non-invasive imaging technique for the micromorphology of the skin. OCT provides in vivo cross sectional tomographic images of tissue in situ and real-time with micrometer resolution. It works analogously to ultrasound; the reflection of infrared light, instead of acoustical waves, from the skin is measured and the signal strength is imaged as a function of position. Depending on the scattering properties of tissue and some accepted loss in resolution, a penetration depth of up to 2 mm can be achieved. The image data are displayed by assigning color or gray scales to each reflection, according to the measured signal strength. The OCT probe is applied directly after application of ultrasound gel to the skin. Acquisition time for an OCT image is approximately 3 seconds.
582 studies on the registry are indexed under Skin Neoplasms; 114 are open to participants now.
This study's enrollment of 37 is below the median of 200 across 134 observational studies indexed under Skin Neoplasms.
Browse Skin Neoplasms studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
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Skin tumor patients with subsequent excision and histopathological analysis at the department of dermatology, Medical University of Vienna
Exclusion Criteria:
Skin cancer patients with scheduled tumor excision and subsequent histopathological analysis of the tumor.
Other: in-vivo skin tumor imaging via optical coherence tomography
optical coherence tomography imaging of skin lesion; digital dermoscopy imaging of skin lesion
Optical coherence tomography (OCT) imaging quality of skin tumor formations versus corresponding histopathology.
Time frame: two years
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Medical University of Vienna