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

Skin Diseases Clinical Trial

— dOCT-pBCC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06279143
• Other study ID #: dOCT-pBCC
• Status: Recruiting
• Start date: April 4, 2024
• Est. completion date: November 30, 2026

Study information

• Verified date: April 2024
• Source: Vejle Hospital
• Contact: Sveina B Karlsdóttir, Ph.D.Student
• Phone: 53 42 04 48
• Email: sveina.bjork.karlsdottir[@]rsyd.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: November 30, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• BCC
• BCC - Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Eyelid Diseases
• Eyelid Tumor
• Skin Diseases

Locations

Country	Name	City	State
Denmark	Department of Ophthalmology, University Hospital of Southern Denmark, Vejle Hospital	Vejle	Region Of Southern Danmark

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of D-OCT in diagnosing BCC inside the periocular region, compared to previous reports on lesions outside the periocular region	To assess if 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 using the standard probe	March 2024-August 2026
Secondary	Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for diagnosing BCC	To compare the sensitivity and specificity of each D-OCT probe for diagnosing periocular BCC, with reference to punch biopsy results.	March 2024-August 2026
Secondary	Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for subtyping BCC	To compare the sensitivity and specificity of each D-OCT probe for subtyping periocular BCC, with reference to punch biopsy results.	March 2024-August 2026
Secondary	Observer agreement in identifying presence/absence of BCC lesions, using D-OCT	This measure, assesses the consistency among observers in identifying the presence or absence of BCC lesions through the utilization of D-OCT imaging.	March 2024-August 2026
Secondary	Observer agreement in classifying BCC lesions into subtypes, using D-OCT	This measure, evaluates the level of agreement among observers in categorizing BCC lesions into specific subtypes based on D-OCT imaging. Potential diagnostic features from lesion types will be tested.	March 2024-August 2026
Secondary	Observer agreement in mapping BCC lesions prior to surgery, using D-OCT	This measure, examines the agreement among observers in accurately mapping the extension of BCC lesions prior to surgery with the assistance of D-OCT imaging.	March 2024-August 2026
Secondary	Quantification of learning curve in correctly diagnosing BCC over time with increasing experience with D-OCT	This measure, quantifies the improvement in skills over time among observers in diagnosing BCC lesions using D-OCT imaging. It aims to determine the rate at which observers become adept at interpreting D-OCT images for BCC diagnosis.	March 2024-August 2026
Secondary	Quantification of learning curve in correctly identifying BCC subtypes over time with increasing experience with D-OCT	This measure, quantifies the improvement in skills over time among observers in accurately identifying different subtypes of BCC lesions using D-OCT imaging. It aims to determine the rate at which observers become adept at interpreting D-OCT images for BCC subtyping.	March 2024-August 2026
Secondary	Quantification of skills in correctly demarcating BCC over time with increasing experience with D-OCT	This measure, quantifies the improvement in skills over time among observers in precisely delineating the borders of BCC lesions prior to surgery using D-OCT imaging. It assesses the improvement in demarcation accuracy with increasing experience.	March 2024-August 2026
Secondary	Accuracy of D-OCT in delineation of periocular BCC extension prior to surgery	Evaluation af sensitivity of D-OCT imaging in delineation (mapping) of periocular BCC tumour extension - comparing findings with visible boundaries and histopathological diagnosis (considered the gold standard)	March 2024-August 2026