cOCT Versus LC-OCT for Diagnosing Basal Cell Carcinoma: a Diagnostic Cohort Study

Study Overview
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Brief Summary
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Basal cell carcinoma (BCC) is the most common form of cancer among the Caucasian population. Equivocal BCC lesions are usually diagnosed by means of a punch biopsy, but since the last few decades, non-invasive imaging techniques for the diagnosis of BCC gained popularity within the field of dermatology. Conventional optical coherence tomography (cOCT) is an example of a non-invasive imaging technique. Recent studies revealed that OCT assessors may achieve high diagnostic certainty and accuracy for diagnosing BCC. However, cOCT has a limited axial and lateral resolution and can therefore only visualize the gross architecture of the skin. It has been proposed that the diagnostic certainty and accuracy of cOCT could be optimized by improving the resolution. Line-field confocal optical coherence tomography (LC-OCT) is a new non-invasive imaging technique that provides tridimensional images of the skin with a cellular resolution. Although the resolution of LC-OCT is superior to cOCT, the penetration depth of LC-OCT (500µm) is limited compared to that of cOCT (1.0-1.5mm). In the proposed study, we aim to assess whether LC-OCT is superior to cOCT in terms of diagnostic accuracy for diagnosing BCC in equivocal BCC lesions.

Official Title
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cOCT Versus LC-OCT for Diagnosing Basal Cell Carcinoma: a Diagnostic Cohort Study

Conditions
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Basal Cell Carcinoma

Intervention / Treatment
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* Device: cOCT and LC-OCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients (18+) with equivocal BCC lesions undergoing biopsy conform regular care Exclusion Criteria: Patients unable to sign informed consent Patients with clinically evident BCC lesions who do not undergo biopsy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with equivocal BCC lesions<br>Patients with equivocal BCC lesions (18+ years) who will undergo biopsy conform regular care will undergo a cOCT and LC-OCT scan. | Device: cOCT and LC-OCT<br>* cOCT: conventional optical coherence tomography (cOCT) is an established imaging modality within dermatology that enables visualization of the architecture of the skin with a penetration depth of 1.0 - 1.5mm. LC-OCT: Line-field confocal optical coherence tomography (LC-OCT) is a new emerging diagnostic modality within the field of dermatology. LC-OCT enables tridimensional imaging of the skin with a cellular resolution and BCC features on LC-OCT have been described. However, the penetration depth of LC-OCT (500µm), is limited compared to the penetration depth of cOCT (1.0-1.5mm)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of cOCT and LC-OCT | Diagnostic parameters such as sensitivity, specificity, PPV, NPV and DOR will be evaluated for diagnosing BCC in patients with equivocal lesions and compared between both imaging devices. | Measured before september 1st 2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy for BCC subtyping on cOCT and LC-OCT | Diagnostic parameter for differentiating BCC subtypes (sBCC/nBCC/iBCC) will be evaluated and compared between both imaging devices. | Measured before september 1st 2024 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Optical coherence tomography, Line-field confocal optical coherence tomography