Actively Recruiting
Applicability of a Cellular Level Resolution Full-field OCT Image System for Diagnosis of Pigmented and Non-pigmented Skin Tumors
Led by Apollo Medical Optics, Ltd · Updated on 2024-12-31
200
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Skin cancer cases, including both melanoma and non-melanoma types, have been steadily rising over recent decades. This research investigates new imaging technologies to improve the diagnosis of pigmented and non-pigmented skin tumors without needing invasive biopsies. The study evaluates the use of a high-resolution optical coherence tomography (OCT) scanner, the ApolloVue ae S100 Image System, which offers detailed skin imaging at the cellular level and combines advantages of existing imaging methods like confocal microscopy and traditional OCT. The study uses the ApolloVue ae S100, a CE-certified device that produces two-dimensional, cross-sectional, and en-face images of the skin in real time. This system employs a special light source and camera to create high-speed, high-resolution images, allowing precise examination of skin lesions. Other imaging devices such as confocal microscopy, Vivascope ae, Vivosight ae OCT, and dermoscopy with DermLite FotoX ae are also used for comparison on a subset of skin lesions. The system's guiding mechanism helps position the probe accurately for detailed scans during the study. Participants with pigmented or non-pigmented skin lesions scheduled for biopsy or excision will undergo imaging assessments using these devices. Researchers will characterize disease features and evaluate diagnostic accuracy over approximately 1.5 years. Data collected includes OCT images, lesion positions, and clinical assessments. This non-invasive imaging study aims to improve skin tumor evaluation while reducing unnecessary biopsies, with no additional treatments given. Participants' progress and skin lesion images will be monitored and recorded throughout the study period.
CONDITIONS
Brief 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 for skin cancer that requires skin biopsy or complete excision
- Benign skin tumor scheduled for excision due to suspicion, irritation, or cosmetic reasons
You will not qualify if you...
- Patients aged < 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1.5 years
Participants undergo non-invasive imaging of skin lesions using several devices including a high resolution full-field OCT system, confocal microscopy, optical coherence tomography imaging, and dermoscopy imaging for assessment.
Visits as scheduled for imaging and assessments depending on lesion evaluation
Duration - Up to 1.5 years
Participants with pigmented and non-pigmented skin lesions are monitored through imaging and clinical follow-up to characterize disease features and diagnostic accuracy over time.
Follow-up visits depending on clinical need and assessment schedule
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here