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
  Purpose

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 Intervention
Non-melanocytic Skin Tumors
Melanocytic Skin Tumors
Other: in-vivo skin tumor imaging via optical coherence tomography

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Improving Diagnosis of Skin Cancer Patients Via Optical Coherence Tomography and Teledermatology- A Pilot Study

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Optical coherence tomography (OCT) imaging quality of skin tumor formations versus corresponding histopathology. [ Time Frame: two years ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
skin cancer
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01680562

Locations
Austria
Department of Dermatology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Michael Binder, MD Medical University of Vienna
  More Information

Additional Information:
No publications provided

Responsible Party: Jessika Weingast, MD, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01680562     History of Changes
Other Study ID Numbers: 1126/2009, 201880
Study First Received: August 28, 2012
Last Updated: September 4, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
in-vivo skin imaging
non-invasive non-melanoma skin cancer diagnostics

Additional relevant MeSH terms:
Neoplasms
Skin Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 21, 2014