Melanocytic Skin Tumors Clinical Trial
Official title:
Improving Diagnosis of Skin Cancer Patients Via Optical Coherence Tomography and Teledermatology- A Pilot Study
| Verified date | September 2012 |
| Source | Medical University of Vienna |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: Ethikkommission |
| Study type | 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.
- 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
| Status | Active, not recruiting |
| Enrollment | 37 |
| Est. completion date | December 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - seborrhoeic warts - nevi - dermatofibroma - basal cell carcinoma - actinic keratosis - squamous cell carcinoma - Bowen's disease - Merkel cell carcinoma - malignant melanoma Exclusion Criteria: - employers of the Medical University of Vienna - patients during compulsory military service - patients with an appointed guardian |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Austria | Department of Dermatology, Medical University of Vienna | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Optical coherence tomography (OCT) imaging quality of skin tumor formations versus corresponding histopathology. | two years | No |