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

Sponsor
Medical University of Graz (Other)
Overall Status
Completed
CT.gov ID
NCT00487864
Collaborator
(none)
30
1
8
3.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Natural History
    Time Perspective:
    Other
    Official Title:
    In Vivo Confocal Scanning Laser Microscopy of Benign Globular, Homogeneous and Reticular Nevi; Comparison With Dermoscopy and Histopathology
    Study Start Date :
    Sep 1, 2006
    Actual Study Completion Date :
    May 1, 2007

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:
      • Presence of a benign, flat, dermoscopically uniform pigmented nevus.
      Exclusion Criteria:
      • Absence of a benign, flat, dermoscopically uniform pigmented nevus.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Department of Dermatology and Venerology, University Hospital Graz Graz Styria Austria 8036

      Sponsors and Collaborators

      • Medical University of Graz

      Investigators

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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00487864
      Other Study ID Numbers:
      • 01
      First Posted:
      Jun 19, 2007
      Last Update Posted:
      Jun 19, 2007
      Last Verified:
      Jun 1, 2007
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Jun 19, 2007