The Diagnostic Accuracy of Advanced Imaging in Identifying Suspected Skin Cancer (Basal Cell Carcinoma) Around the Eyes

NCT ID: NCT06279143

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 210 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-04
• Study Completion Date: 2027-04-20

Brief 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

Conditions

BCC - Basal Cell Carcinoma; BCC; Skin Diseases; Eyelid Tumor; Eyelid Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vejle Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Flemming Møller, Assoc.prof.

Role: STUDY_DIRECTOR

Vejle Hospital

Locations

Department of Ophthalmology, University Hospital of Southern Denmark, Vejle Hospital

Vejle, Region of Southern Danmark, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Sveina B Karlsdóttir, Ph.D.Student

Role: CONTACT

sveina.bjork.karlsdottir@rsyd.dk

53 42 04 48 ext. +45

Flemming Møller, Assoc.prof.

Role: CONTACT

flemming.moller2@rsyd.dk

22 56 41 83 ext. +45

Facility Contacts

Sveina B Karlsdóttir, MD

Role: primary

sveina@outlook.dk

53420448 ext. 0045

Susanne Støvring

Role: backup

susanne.stoevring@rsyd.dk

79406461 ext. 0045

Other Identifiers

dOCT-pBCC

Identifier Type: -

Identifier Source: org_study_id