In-vivo Optical Coherence Tomography Imaging in Dermatooncology
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|ClinicalTrials.gov Identifier: NCT01680562|
Recruitment Status : Unknown
Verified September 2012 by Jessika Weingast, MD, Medical University of Vienna.
Recruitment status was: Active, not recruiting
First Posted : September 7, 2012
Last Update Posted : September 7, 2012
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.
- To correlate the morphologic features identified with ultrahigh resolution OCT with routine histopathology
- To investigate the clinical feasibility of ultrahigh resolution and spectroscopic OCT technology
- To assess the effectiveness of ultrahigh resolution and spectroscopic OCT imaging to diagnose various melanocytic and non-melanocytic skin tumors
- To compare the diagnostic capabilities of ultrahigh resolution OCT with standard non-invasive diagnostic procedures such as epiluminescence microscopy
|Condition or disease||Intervention/treatment|
|Non-melanocytic Skin Tumors Melanocytic Skin Tumors||Other: in-vivo skin tumor imaging via optical coherence tomography|
|Study Type :||Observational|
|Actual Enrollment :||37 participants|
|Official Title:||Improving Diagnosis of Skin Cancer Patients Via Optical Coherence Tomography and Teledermatology- A Pilot Study|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||July 2012|
|Estimated Study Completion Date :||December 2012|
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680562
|Department of Dermatology, Medical University of Vienna|
|Vienna, Austria, 1090|
|Principal Investigator:||Michael Binder, MD||Medical University of Vienna|