In Vivo Confocal Scanning Laser Microscopy of Benign Nevi (CSLM-nevi)

June 18, 2007 updated by: Medical University of Graz

In Vivo Confocal Scanning Laser Microscopy of Benign Globular, Homogeneous and Reticular Nevi; Comparison With Dermoscopy and Histopathology

In vivo confocal laser scanning microscopy (CLSM) offers the possibility to non-invasively investigate skin lesions at nearly histologic resolution. A recent study showed a high sensitivity (97.6%) and specificity (88.15%) for the discrimination of clinical clear cut melanocytic lesions. CSLM provides horizontal images and can be seen as missing link between dermoscopy and histopathology. For a more accurate diagnosis of dermoscopically difficult to diagnose melanocytic skin lesions in the grey zone between nevus and melanoma, the knowledge of CLSM features of benign nevi seems to be essential. We investigated 30 flat benign nevi with different dermoscopic patterns (10 reticular, 10 globular, 10 homogeneous) nevi. CLSM images were assessed in terms of cytomorphologic and architectural criteria. Different dermoscopic patterns of benign nevi are reflected in different architectural features in CLSM.

Study Overview

Status

Completed

Conditions

Detailed Description

This study included 29 patients, which were recruited consecutively at our pigmented skin lesion clinic at the Department of Dermatology, University Hospital Graz, Austria. A total of 30 benign nevi were imaged; 10 dermoscopically reticular, 10 globular and 10 homogeneous nevi were selected. Lesions were selected for the presence of a uniform dermoscopic pattern. A biopsy of one nevus of each group was performed due to cosmetic purposes on patient's request.

Each nevus was imaged with a confocal scanning laser microscope (Vivascope 1000, Lucid Inc, Henrietta, NY). Technical details of the confocal scanning microscope have been described elsewhere. The adaptor ring of the laser microscope was applied to the skin and centered on the lesion. A standardized evaluation was performed; CSLM imaging of the lesion centre was started stepwise (approximately 20µm per step) beginning from stratum corneum to the papillary dermis with a field of view of 475 x 350 µm for a single image (´stack´ image). Each image corresponds to a horizontal section at a selected depth with a resolution of 640x480 pixels and 255 colors (grey scale). An automated stepper was used to obtain a grid of 16 contiguous horizontal images of the basal layer, constructing a montage image with a 1.9x1.4mm field of view (´block´ image). Since selected nevi showed a uniform pigmentation pattern throughout the whole lesion, a correlation between clinical, dermoscopic and confocal images could be guaranteed. One nevus of each group was consecutively biopsied and assessed with conventional histopathologic examination after sectioning and staining with hematoxylin and eosin (H&E).

Cytomorphologic and architectural features of each nevus were evaluated during assessment of confocal images and distinct characteristics for each group of nevi were determined and correlated with dermoscopy and, if available, with histopathology. The diagnostic applicability of CSLM in the differentiation between reticular, globular and homogeneous nevi based on these features was assessed by two independent observers.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Styria
      • Graz, Styria, Austria, 8036
        • Department of Dermatology and Venerology, University Hospital Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of a benign, flat, dermoscopically uniform pigmented nevus.

Exclusion Criteria:

  • Absence of a benign, flat, dermoscopically uniform pigmented nevus.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rainer Hofmann-Wellenhof, Prof., Department of Dermatology, Medical University Graz, Austria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

June 18, 2007

First Submitted That Met QC Criteria

June 18, 2007

First Posted (Estimate)

June 19, 2007

Study Record Updates

Last Update Posted (Estimate)

June 19, 2007

Last Update Submitted That Met QC Criteria

June 18, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Other Study ID Numbers

  • 01 (Leona M. and Harry B. Helmsley Charitable Trust)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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