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VivaNet Study. A Multicenter Study of Confocal Reflectance Microscopy in Telemedicine

5 Years
Open (Enrolling)
Skin Cancer, Skin Lesions

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Trial Information

VivaNet Study. A Multicenter Study of Confocal Reflectance Microscopy in Telemedicine

In vivo confocal reflectance microscopy (CRM) is a non-invasive method for the in vivo
(without cutting into the skik) examination of skin tumors. CRM produces cellular images
with resolution comparable to histopathology. The procedure is painless, takes about ten
minutes and has no documented side effects. Studies performed in the past decade have
correlated CRM features in benign (non-cancerous) and malignant (cancerous) skin lesions
such as moles and melanomas, as well as features of inflammatory lesions (such as allergic
skin reactions) to histopathology.

Dermoscopy is a complementary technique that has been proven to be superior to the naked eye
for the diagnosis of melanoma as well as some non-melanocytic skin tumors. Recently,
correlation of dermoscopic and CRM structures has focused interest in the research in
different groups that show that both are complementary and render in combination a better
understanding of skin disease.

In this study, patients from several research centers in Europe, with lesions suspicious for
malignancy and scheduled for biopsy will be asked if they would like to participate in the
study. If they consent to the study, first, a clinical photograph will be taken of the
lesion. Second, a dermoscopic image will be taken of the lesion, and third, CRM images will
be taken of the lesion. Finally, the biopsy will be performed as per the standard of care.
The images will be sent over a secure, private internet connection to physicians specially
trained in the interpretation of dermoscopic and CRM images. An electronic report will be
completed and returned to the Study Coordinator, who will correlate the results with the
histopathologic diagnosis.

Inclusion Criteria:

- Any skin tumor considered suspicious for malignancy under clinical non-aided

- Histopathologic study of the tumor or short term follow up (3 months) to confirm

- Clinical information and images available

- Adequate imaging by dermoscopy and CRM according to the protocol of the study

- Consent form signed by the patient

Exclusion Criteria:

- Lesions with ulcerations obscuring more than 75% of the confocal mosaic field of

- Lesions with clinically appreciable scar.

- Lesions in locations not amenable to imaging with the confocal microscope.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Outcome Measure:

Diagnostic accuracy, in terms of sensitivity, specificity, positive and negative predictive values with respect to histopathologic diagnosis.

Outcome Description:

Clinical pictures, dermoscopic pictures, confocal images and tissue biopsy will be obtained in a single study visit unless the physician determines that short-term (3 months) follow up is more appropriate, then the patient will be asked to return in three months for additional examination.

Outcome Time Frame:

Study participation will be no longer than three months for patients requiring follow up, and no longer than one office visit (approximately one hour) for patients being biopsied the same day they are imaged.

Safety Issue:


Principal Investigator

Josep Malvehy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Clinic of Barcelona, Spain


Spain: Ethics Committee

Study ID:




Start Date:

April 2011

Completion Date:

May 2013

Related Keywords:

  • Skin Cancer
  • Skin Lesions
  • Reflectance Confocal Microscopy
  • Dermoscopy
  • Clinical Photos
  • Telemedicine
  • Skin Neoplasms