cOCT Versus LC-OCT for Diagnosing Basal Cell Carcinoma: a Diagnostic Cohort Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with equivocal BCC lesions 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
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)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Maastricht University Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-0086