Evaluating advanced imaging for diagnosing skin cancer around the eyes
The Diagnostic Value of Dermal Optical Coherence Tomography (D-OCT) for Clinically Suspected Basal Cell Carcinoma Lesion (BCC) in the Periocular Area
This study is testing a new imaging technique to see if it can help doctors better diagnose skin cancer around the eyes in people who might have it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vejle Hospital Academic / other |
| Locations | 1 site (Vejle, Region of Southern Danmark) |
| Trial ID | NCT06279143 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the diagnostic accuracy of dermal-Optical Coherence Tomography (D-OCT) in identifying basal cell carcinoma (BCC) lesions in the periocular region. It will compare the sensitivity and specificity of D-OCT using both standard and customized probes against previous findings for lesions outside this area. The study will also evaluate the ability of D-OCT to subtype periocular BCC and analyze inter-observer variation in diagnosis. Participants will include individuals with clinically suspected or biopsy-verified BCC.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with clinically suspected or biopsy-verified periocular basal cell carcinoma.
Not a fit: Patients with anatomical issues preventing OCT scanning or those unwilling to undergo a biopsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing skin cancer around the eyes, leading to better patient outcomes.
How similar studies have performed: Previous studies have shown promising results for D-OCT in diagnosing BCC, but this specific application in the periocular region is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinically suspected periocular BCC. * Biopsy-verified BCC * Clinically suspected relapse of periocular BCC * Age more than 18 years at baseline. * Legally competent, able to give verbal and written consent * Communicate in Danish verbally as well as in writing * Willingness to participate and able to give informed consent and can comply with protocol requirements. Exclusion Criteria: * Anatomical circumstances that make OCT-scanning impossible, i.e., extensive scarring of eyelids, or large ulcerating crusts that hampers scanning * Unwillingness to undergo a skin biopsy or excision of lesion. * Inability to sign informed consent.
Where this trial is running
Vejle, Region of Southern Danmark
- Department of Ophthalmology, University Hospital of Southern Denmark, Vejle Hospital — Vejle, Region of Southern Danmark, Denmark (Recruiting)
Study contacts
- Study coordinator: Sveina B Karlsdóttir, Ph.D.Student
- Email: sveina.bjork.karlsdottir@rsyd.dk
- Phone: 53 42 04 48
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.