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

Skin Cancer Clinical Trial

— EUNET  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01385943
• Other study ID #: 2009/4714
• Status: Withdrawn
• Start date: April 2011
• Est. completion date: December 1, 2015

Study information

• Verified date: November 2019
• Source: Lucid, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2015
• Est. primary completion date: December 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Skin Cancer
• Skin Lesions
• Skin Neoplasms

Locations

Country	Name	City	State
Italy	University of Modena and Reggio Emilia	Modena
Italy	Arcispedale Santa Maria Nuova	Reggio Emilia
Spain	Department of Dermatology, Hospital del Mar	Barcelona
Spain	Diagnosis Dermatologica	Barcelona
Spain	Hospital Clinic of Barcelona	Barcelona
Spain	Hospital Ramón y Cajal	Madrid

Sponsors (6)

Lead Sponsor	Collaborator
Lucid, Inc.	Arcispedale Santa Maria Nuova-IRCCS, Hospital Clinic of Barcelona, Hospital del Mar, Hospital Universitario Ramon y Cajal, University of Modena and Reggio Emilia

Countries where clinical trial is conducted

Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.