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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Skin Diseases; Eyelid Diseases; Eyelid Tumor; BCC; BCC - Basal Cell Carcinoma

• Study Type: Observational
• Enrollment (Estimated): 210

Contacts and Locations

• Study Contact: Name: Sveina B Karlsdóttir, Ph.D.Student; Phone Number: +45 53 42 04 48; Email: sveina.bjork.karlsdottir@rsyd.dk
• Study Contact Backup: Name: Flemming Møller, Assoc.prof.; Phone Number: +45 22 56 41 83; Email: flemming.moller2@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive enrolment of newly referred patients under the diagnosis "clinically suspected BCC" in the periocular area

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Vejle Hospital
• Investigators: Study Director: Flemming Møller, Assoc.prof., Vejle Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 22, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Estimated): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Diagnostic imaging; Skin neoplasm; BCC; Sensitivity and Specificity; Skin diseases; Periocular; Carcinoma, Basal Cell* / diagnostic imaging; Carcinoma, Basal Cell* / pathology; Carcinoma, Basal Cell* / surgery; Neoplasm, Glandular and epithelial; Tomography, Optical Coherence* / methods; Skin Neoplasm* / surgery; Neoplasm recurrence; Eyelids / pathology
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Eye Diseases; Neoplasms, Basal Cell; Carcinoma; Skin Diseases; Carcinoma, Basal Cell; Eyelid Diseases
• Other Study ID Numbers: dOCT-pBCC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No