D-OCT for Detection and Subtyping of BCC: a Diagnostic Cohort Study

Basal Cell Carcinoma Clinical Trial

Official title:

Dynamic Optical Coherence Tomography for Detection and Subtyping of Basal Cell

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06273722
• Other study ID #: 2024-0059
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Maastricht University Medical Center
• Contact: Tom Wolswijk, MD MSc
• Phone: +31(0)43- 387 7295
• Email: tom.wolswijk[@]mumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The current gold standard for diagnosing basal cell carcinoma (BCC) is the histopathological examination of biopsy specimen. However, non-invasive imaging modalities such as optical coherence tomography (OCT) may replace biopsy if BCC presence and its subtype can be established with high confidence. Subtype differentiation is crucial; while superficial BCCs (sBCC) can be treated topically, nodular (nBCC) and infiltrative BCCs (iBCC) require excision. Dynamic OCT (D-OCT) is a functionality integrated within the OCT device, enabling the visualization of vascular structures through speckle variance. Descriptive studies have unveiled vascular shapes and patterns associated with BCC and its respective subtypes. These findings suggest that D-OCT could contribute to the accuracy of BCC detection and subtyping. Yet comparative clinical studies between OCT and D-OCT are lacking. In the proposed diagnostic cohort study, we aim to assess whether D-OCT assessment is superior to OCT in terms of accuracy for BCC detection and subtyping.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 424
• Est. completion date: December 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18+ years
• Lesions suspect for non-melanoma skin cancer or premalignancy
• Patient underwent D-OCT scan and biopsy conform regular care

Exclusion Criteria:

• Patient unable to sign informed consent.

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma, Basal Cell
• Optical Coherence Tomography

Intervention

Device:
• Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner
Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner (Michelson Diagnostics Maidstone, Kent, UK; resolution <7.5 µm lateral, <5 µm axial; depth of focus 1.0 mm; scan area 6 × 6 mm).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy for BCC detection on D-OCT assessment	We will evaluate the ability of OCT assessors to discriminate BCC from non-BCC using OCT without and with dynamic functionality. The diagnostic certainty for BCC detection will be expressed on a five-point confidence scale. A high confidence score (confidence score=4) is considered a positive OCT test results. In these cases, biopsy could effectively be omitted. Lower confidence scores (confidence score=3) are considered negative OCT test results as in these cases, biopsy remains necessary for a definitive or alternative diagnosis. The primary outcome of interest is the sensitivity of a high confidence BCC diagnosis because we want to evaluate whether the dynamic functionality increases the proportion of correctly classified BCCs.	Measured before December 31st 2024
Secondary	Diagnostic accuracy for BCC subtyping on D-OCT assessment	We will evaluate the ability of OCT assessors to discriminate each individual BCC subtype from the other two subtypes using OCT without and with dynamic functionality. Cases that resulted in a high confidence diagnosis (confidence score=4) will be included in the analyses. Three analyses will be performed to calculate the sensitivity to detect sBCC, nBCC or iBCC and the specificity to identify non-sBCC, non-nBCC or non-iBCC subtypes using histopathology as reference test. In this respect, sensitivity is defined as the proportion of a specific BCC subtype, that is correctly classified as such by the OCT assessor (i.e. sBCC, nBCC or iBCC), whereas specificity is defined as the proportion of the other two subtypes that is correctly classified as such (i.e sBCC/nBCC, sBCC/iBCC or nBCC/iBCC). The primary outcome of interest is the sensitivity. We want to evaluate whether the dynamic functionality increases the proportion of correctly classified subtypes .	Measured before December 31st 2024
Secondary	Diagnostic value of vascular structures and patterns	Diagnostic odds ratios (DORs ) are used to identify subsets of vascular features and patterns that can be used to accurately discriminate BCC subtypes. The histopathological subtype (i.e. sBCC, nBCC, iBCC ) vs. other subtypes (i.e sBCC/nBCC, sBCC/iBCC, nBCC/iBCC) will be used as the dependent variable. A DOR >1 indicates that the presence of a vascular feature or pattern is indicative for the presence of the respective BCC subtype.	Measured before December 31st 2024