cOCT Versus LC-OCT for Diagnosing Basal Cell Carcinoma: a Diagnostic Cohort Study
- Conditions
- Basal Cell Carcinoma
- Interventions
- Device: cOCT and LC-OCT
- Registration Number
- NCT06024629
- Lead Sponsor
- Maastricht University Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 197
- Patients (18+) with equivocal BCC lesions undergoing biopsy conform regular care
- Patients unable to sign informed consent
- Patients with clinically evident BCC lesions who do not undergo biopsy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with equivocal BCC lesions cOCT and LC-OCT Patients with equivocal BCC lesions (18+ years) who will undergo biopsy conform regular care will undergo a cOCT and LC-OCT scan.
- Primary Outcome Measures
Name Time Method Diagnostic accuracy of cOCT and LC-OCT Measured before september 1st 2024 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.
- Secondary Outcome Measures
Name Time Method Diagnostic accuracy for BCC subtyping on cOCT and LC-OCT Measured before september 1st 2024 Diagnostic parameter for differentiating BCC subtypes (sBCC/nBCC/iBCC) will be evaluated and compared between both imaging devices.
Trial Locations
- Locations (1)
Maastricht UMC+
🇳🇱Maastricht, Netherlands