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Applicability of a Cellular Resolution Full-field OCT Image System for Pigmented and Non-pigmented Skin Tumors

NCT05068310 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-12-31

No results posted yet for this study

Summary

The incidence of skin cancer has been continuously increasing over the past decades und the number of non melanoma skin cancer is well as melanoma is still going to increase. Invasive biopsy and histological examination represents the gold standard in diagnosis of benign and malignant skin tumors. However, novel technologies such as reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) have been introduced in dermatology. Multiple studies have shown the applicability of both technologies for diagnosis of skin tumors as well as other skin diseases and to increase the specificity of diagnosis resulting in the reduction of unnecessary biopsies.

New technological developments resulted in a high resolution OCT scanner (AMO, Taiwan), which allows vertical and horizontal evaluation (3D) of the skin at cellular resolution and up to a depth of around 400 μm and thus combines the advantages of both above mentioned techniques. ApolloVue® S100 Image System is a FDA-cleared 510(k) Class II medical device.

Other non-invasive imaging method (reflectance confocal microscopy and conventional optical coherence tomography) will be used to evaluate a subset of skin lesions.

Conditions

Interventions

DEVICE

Cellular resolution full-field optical coherence tomography

Device: ApolloVue® S100 Image System

DEVICE

Confocal microscopy

Device: Vivascope® will be used for skin imaging for a subset of skin lesions.

DEVICE

Optical coherence tomography imaging

Device: Vivosight® will be used for skin imaging for a subset of skin lesions.

DEVICE

Dermoscopy imaging

Device: Dermoscopy imaging will be conducted using but not limited to dermoscope DermLite FotoX®

Sponsors & Collaborators

  • Apollo Medical Optics, Ltd

    lead INDUSTRY

Principal Investigators

  • Martina Ulrich, MD · CMB COLLEGIUM MEDICUM BERLIN GmbH

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-21
Primary Completion
2025-01-31
Completion
2025-02-28
FDA Device
Yes

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05068310 on ClinicalTrials.gov