Actively Recruiting

Age: 18Years +
All Genders
ID05068310

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

Led by Apollo Medical Optics, Ltd · Updated on 2024-12-31

200

Participants Needed

1

Research Sites

171 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The incidence of skin cancer, including non-melanoma and melanoma types, has been rising steadily over recent decades. Traditional diagnosis relies on invasive biopsy and histological examination, but new imaging technologies like reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) are being explored to improve diagnosis accuracy and reduce unnecessary biopsies. This research evaluates a novel high-resolution OCT scanner called the ApolloVueAE S100 Image System, which provides detailed cellular-level images of pigmented and non-pigmented skin tumors, aiming to advance non-invasive skin cancer diagnosis. The study uses the ApolloVueAE S100 System, a CE-certified device that captures two-dimensional cross-sectional and en-face images of the skin in real time. This system combines vertical and horizontal evaluation at a depth of around 400 micrometers with cellular resolution and offers fast scanning speeds without depth-of-field limitations. Participants' skin lesions will also be imaged using other devices such as VivascopeAE confocal microscopy, VivosightAE optical coherence tomography, and DermLite FotoXAE dermoscopy for comparison and evaluation of a subset of lesions. During the 1.5-year study, participants will undergo high-resolution OCT imaging and other non-invasive scans to assess their skin lesions. The study will record images and lesion positions for follow-up and monitor disease features of pigmented and non-pigmented skin lesions. Researchers will evaluate the detailed skin structures captured and compare imaging results to improve diagnosis accuracy. Participants' involvement includes skin lesion imaging, data collection, and image management throughout the study.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged > 18 years
  • Willingness to participate in this study including the assessment with high resolution OCT
  • Skin lesion or tumor suspected of skin cancer requiring biopsy or complete removal
  • Benign skin tumor planned for removal due to suspicion, irritation, or cosmetic reasons
Not Eligible

You will not qualify if you...

  • Patients younger than 18 years
  • Any unstable medical or psychological conditions
  • Unwillingness to participate in this study including the assessment with high resolution OCT

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CMB COLLEGIUM MEDICUM BERLIN GmbH

Berlin, Germany

Actively Recruiting

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Research Team

E

Emily Tsai, PhD

H

Hsin Cheng

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Frequently Asked Questions

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