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

NCT06279143 | Recruiting

• 1 other identifier: dOCT-pBCC
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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

Keywords

Carcinoma, Basal Cell* / diagnostic imaging; Carcinoma, Basal Cell* / pathology; Carcinoma, Basal Cell* / surgery; Neoplasm, Glandular and epithelial; Skin neoplasm; Diagnostic imaging; Sensitivity and Specificity; Tomography, Optical Coherence* / methods; Skin Neoplasm* / surgery; Neoplasm recurrence; Eyelids / pathology; Skin diseases; Periocular; BCC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for diagnosing BCC

  March 2024-August 2026

• Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for subtyping BCC

  March 2024-August 2026

• Observer agreement in identifying presence/absence of BCC lesions, using D-OCT

  March 2024-August 2026

• Observer agreement in classifying BCC lesions into subtypes, using D-OCT

  March 2024-August 2026

• Observer agreement in mapping BCC lesions prior to surgery, using D-OCT

  March 2024-August 2026

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

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

Vejle, Region of Southern Danmark, 7100, Denmark

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal Cell; Skin Diseases; Eyelid Neoplasms; Eyelid Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Skin Neoplasms; Hypersensitivity; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Skin and Connective Tissue Diseases; Facial Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Eye Neoplasms; Eye Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Flemming Møller, Assoc.prof.

  Vejle Hospital

  STUDY DIRECTOR

Central Study Contacts

Sveina B Karlsdóttir, Ph.D.Student

CONTACT

53 42 04 48; sveina.bjork.karlsdottir@rsyd.dk

Flemming Møller, Assoc.prof.

CONTACT

22 56 41 83; flemming.moller2@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 26, 2024
• Study Start: April 4, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): April 20, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

DK (1)