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

NCT06024629 | Active Not Recruiting

• 1 other identifier: 2023-0086
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 1

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.

Conditions

Basal Cell Carcinoma

Keywords

Optical coherence tomography; Line-field confocal optical coherence tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Diagnostic accuracy for BCC subtyping on cOCT and LC-OCT

  Measured before september 1st 2024

Study Arms (1)

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

Interventions

cOCT and LC-OCT DEVICE

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)

Patients with equivocal BCC lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients visiting the outpatient clinic of Maastricht University Medical Center+ (MUMC+). All included patients (18+) will undergo a punch biopsie for their equivocal BCC lesion conform regular care.

You may qualify if:

• Patients (18+) with equivocal BCC lesions undergoing biopsy conform regular care

You may not qualify if:

• Patients unable to sign informed consent
• Patients with clinically evident BCC lesions who do not undergo biopsy

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht UMC+

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 6, 2023
• Study Start: September 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: September 1, 2024
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

NL (1)