In-vivo Optical Coherence Tomography Imaging in Dermatooncology

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Medical University of Vienna.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Jessika Weingast, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01680562
First received: August 28, 2012
Last updated: September 4, 2012
Last verified: September 2012

August 28, 2012
September 4, 2012
January 2010
July 2012   (final data collection date for primary outcome measure)
Optical coherence tomography (OCT) imaging quality of skin tumor formations versus corresponding histopathology. [ Time Frame: two years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01680562 on ClinicalTrials.gov Archive Site
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In-vivo Optical Coherence Tomography Imaging in Dermatooncology
Improving Diagnosis of Skin Cancer Patients Via Optical Coherence Tomography and Teledermatology- A Pilot Study

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

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Skin tumor patients with subsequent excision and histopathological analysis at the department of dermatology, Medical University of Vienna

  • Non-melanocytic Skin Tumors
  • Melanocytic Skin Tumors
Other: in-vivo skin tumor imaging via optical coherence tomography
optical coherence tomography imaging of skin lesion; digital dermoscopy imaging of skin lesion
skin cancer
Skin cancer patients with scheduled tumor excision and subsequent histopathological analysis of the tumor.
Intervention: Other: in-vivo skin tumor imaging via optical coherence tomography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
37
December 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01680562
1126/2009, 201880
No
Jessika Weingast, MD, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Michael Binder, MD Medical University of Vienna
Medical University of Vienna
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP