VivaNet Study. A Multicenter Study of Confocal Reflectance Microscopy in Telemedicine (EUNET)

The goal of this study is to test a protocol that uses clinical pictures, confocal reflectance microscopy images and dermoscopic information in a telemedicine platform. This protocol will test the technologies and diagnostic performance of dermoscopy and confocal reflectance microscopy in a randomized prospective multicenter study in five different centers in Europe.

Study Overview

• Status: Withdrawn
• Conditions: Skin Cancer; Skin Lesions

Detailed Description

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• Italy
  • Modena, Italy, 42100
    • University of Modena and Reggio Emilia
  • Reggio Emilia, Italy, 42100
    • Arcispedale Santa Maria Nuova
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic of Barcelona
  • Barcelona, Spain, 08003
    • Department of Dermatology, Hospital del Mar
  • Barcelona, Spain, 08015
    • Diagnosis Dermatologica
  • Madrid, Spain, 28049
    • Hospital Ramon y Cajal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients from private dermatology clinics and university dermatology practices throughout Europe that have a skin lesion suspicious for malignancy under clinical non-aided examination.

Description

Inclusion Criteria:

• Any skin tumor considered suspicious for malignancy under clinical non-aided examination
• Histopathologic study of the tumor or short term follow up (3 months) to confirm benignity
• 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 view.
• Lesions with clinically appreciable scar.
• Lesions in locations not amenable to imaging with the confocal microscope.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Skin Cancer; Patients from dermatology practices throughout Europe that have a skin lesion or tumor requiring a biopsy for diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy, in terms of sensitivity, specificity, positive and negative predictive values with respect to histopathologic diagnosis.	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences between dermoscopy/confocal microscopy, and dermoscopy plus confocal microscopy	Clinical pictures, dermoscopic pictures, confocal images and tissue biopsy will be obtained in a single study visit as described under Primary Outcomes, 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.	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.

Collaborators and Investigators

• Sponsor: Lucid, Inc.
• Collaborators: Hospital Clinic of Barcelona; Hospital Universitario Ramon y Cajal; Hospital del Mar; University of Modena and Reggio Emilia; Arcispedale Santa Maria Nuova-IRCCS
• Investigators: Principal Investigator: Josep Malvehy, MD, Hospital Clinic of Barcelona, Spain; Principal Investigator: Giovanni Pellacani, MD, Policlinico Hospitale in Modena, Italy

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 28, 2011
• First Submitted That Met QC Criteria: June 29, 2011
• First Posted (Estimate): June 30, 2011

Study Record Updates

• Last Update Posted (Actual): November 8, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Telemedicine; Dermoscopy; Reflectance Confocal Microscopy; Clinical Photos
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms
• Other Study ID Numbers: 2009/4714