Actively Recruiting
The Diagnostic Accuracy of Advanced Imaging in Identifying Suspected Skin Cancer (Basal Cell Carcinoma) Around the Eyes
Led by Vejle Hospital · Updated on 2025-05-20
210
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose is to investigate the diagnostic value (sensitivity and specificity) of dermal-Optical Coherence Tomography (D-OCT, VivoSight Dx), in patients with clinically suspected BCC lesions inside the periocular region and compare these results to previous reports using D-OCT in diagnosing lesions outside the periocular area. The Hypotheses: * The sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is comparable to previous reports on BCC lesions outside the periocular region when the standard D-OCT probe is used. * The sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is increased when the customised D-OCT probe is used. * The sensitivity and specificity of D-OCT in diagnosing periocular BCC is comparable to punch biopsy when both standard and the customised D-OCT probes are used. * D-OCT with the 10 and 20-millimeter standoff is capable of subtyping periocular BCC. * The inter-observer variation in diagnosing and sub-typing periocular BCC decreases with increasing experience in the scanning procedure. * The number of scans to correctly interpret D-OCT decreases with increasing experience in the scanning procedure. * Delineation of periocular BCC tumour extension is possible using both D-OCT probes
CONDITIONS
Official Title
The Diagnostic Accuracy of Advanced Imaging in Identifying Suspected Skin Cancer (Basal Cell Carcinoma) Around the Eyes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically suspected periocular basal cell carcinoma (BCC)
- Biopsy-verified BCC
- Clinically suspected relapse of periocular BCC
- Age more than 18 years at baseline
- Legally competent and able to give verbal and written consent
- Able to communicate in Danish verbally and in writing
- Willingness to participate and able to give informed consent
- Ability to comply with study protocol requirements
You will not qualify if you...
- Anatomical issues preventing OCT scanning, such as extensive eyelid scarring or large ulcerating crusts
- Unwillingness to undergo skin biopsy or lesion excision
- Inability to sign informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Ophthalmology, University Hospital of Southern Denmark, Vejle Hospital
Vejle, Region of Southern Danmark, Denmark, 7100
Actively Recruiting
Research Team
S
Sveina B Karlsdóttir, Ph.D.Student
CONTACT
F
Flemming Møller, Assoc.prof.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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