NevusCSLM-neviNCT00487864
In Vivo Confocal Scanning Laser Microscopy of Benign Nevi
An observational study of Nevus, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nevus
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2006to May 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Presence of a benign, flat, dermoscopically uniform pigmented nevus.
Who cannot join
- Absence of a benign, flat, dermoscopically uniform pigmented nevus.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Dermatology and Venerology, University Hospital Graz
Graz, Styria, 8036
About this study
Official title: 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.
Read the 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.
- Conditions
- Nevus
- Medical subject headings
- Nevus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2007 (estimated)
- Study startSep 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NevusStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Natural history
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Investigators
- Rainer Hofmann-Wellenhof, Prof., Principal investigator, Department of Dermatology, Medical University Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487864
- Sponsor's protocol ID
- 01
- Acronym
- CSLM-nevi
- Status last verified
- Jun 2007
- First submitted
- 18 Jun 2007
- Last updated
- 19 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Confocal Scanning Laser Microscopy of Benign Globular, Homogeneous and Reticular Nevi; Comparison With Dermoscopy and Histopathology
- ClinicalTrials.gov ID
- NCT00487864
- Acronym / sponsor ID
- CSLM-nevi / 01
- Conditions
- Nevus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- May 2007 (actual)
- First posted
- 19 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Natural history
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of a benign, flat, dermoscopically uniform pigmented nevus.
Key exclusion criteria (1 listed)
- Absence of a benign, flat, dermoscopically uniform pigmented nevus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Hofmann-Wellenhof, Prof. principal investigator
Department of Dermatology, Medical University Graz, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nevus, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2007.