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

Basal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06024629
• Other study ID #: 2023-0086
• Status: Active, not recruiting
• Start date: September 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2024
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 197
• Est. completion date: September 1, 2024
• Est. primary completion date: February 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

Intervention

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)

Locations

Country	Name	City	State
Netherlands	Maastricht UMC+	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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