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Completed

NCT Number: NCT06279143

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

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

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Key information

Conditions

BCC - Basal Cell Carcinoma BCC Carcinoma Carcinoma, Basal Cell Disease Attributes Eye Diseases Eye Neoplasms Eyelid Diseases Eyelid Neoplasms Eyelid Tumor Facial Neoplasms Head and Neck Neoplasms Hypersensitivity Immune System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Vejle, Region of Southern Danmark, 7100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

    Time frame: March 2024-August 2026

    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

Secondary outcomes

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

    Time frame: March 2024-August 2026

    To compare the sensitivity and specificity of each D-OCT probe for diagnosing periocular BCC, with reference to punch biopsy results.

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

    Time frame: March 2024-August 2026

    To compare the sensitivity and specificity of each D-OCT probe for subtyping periocular BCC, with reference to punch biopsy results.

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

    Time frame: March 2024-August 2026

    This measure, assesses the consistency among observers in identifying the presence or absence of BCC lesions through the utilization of D-OCT imaging.

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

    Time frame: March 2024-August 2026

    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.

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

    Time frame: March 2024-August 2026

    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.

  6. Quantification of learning curve in correctly diagnosing BCC over time with increasing experience with D-OCT

    Time frame: March 2024-August 2026

    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.

  7. Quantification of learning curve in correctly identifying BCC subtypes over time with increasing experience with D-OCT

    Time frame: March 2024-August 2026

    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.

  8. Quantification of skills in correctly demarcating BCC over time with increasing experience with D-OCT

    Time frame: March 2024-August 2026

    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.

  9. Accuracy of D-OCT in delineation of periocular BCC extension prior to surgery

    Time frame: March 2024-August 2026

    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)

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study title

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

Acronym: dOCT-pBCC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 26, 2024
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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