The Diagnostic Value of Dermal Optical Coherence Tomography (D-OCT) for Clinically Suspected Basal Cell Carcinoma Lesion (BCC) in the Periocular Area

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Department of Ophthalmology, University Hospital of Southern Denmark, Vejle Hospital
RECRUITING
Vejle
Contact Information
Primary
Sveina B Karlsdóttir, Ph.D.Student
sveina.bjork.karlsdottir@rsyd.dk
53 42 04 48
Backup
Flemming Møller, Assoc.prof.
flemming.moller2@rsyd.dk
22 56 41 83
Time Frame
Start Date: 2024-04-04
Estimated Completion Date: 2027-04-20
Participants
Target number of participants: 210
Related Therapeutic Areas
Sponsors
Leads: Vejle Hospital

This content was sourced from clinicaltrials.gov