Actively Recruiting
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 ApolloVue AE 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 ApolloVue AE 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 Vivascope AE confocal microscopy, Vivosight AE optical coherence tomography, and DermLite FotoX AE 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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
CMB COLLEGIUM MEDICUM BERLIN GmbH
Berlin, Germany
Actively Recruiting
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
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