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

Vejle Hospital

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06279143

dOCT-pBCC

Details and patient eligibility

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

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.