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

Dynamic Optical Coherence Tomography for Detection and Subtyping of Basal Cell

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Basal Cell Carcinoma; Optical Coherence Tomography
• Intervention / Treatment: Device: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner

• Study Type: Observational
• Enrollment (Estimated): 424

Contacts and Locations

• Study Contact: Name: Tom Wolswijk, MD MSc; Phone Number: +31(0)43- 387 7295; Email: tom.wolswijk@mumc.nl
• Study Contact Backup: Name: Klara Mosterd, MD PhD; Phone Number: +31(0)43- 387 7295

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This diagnostic cohort study will include patients (18+ years) who underwent a biopsy and D-OCT scan for lesions suspect for BCC skin cancer. Patient data was retrieved from a pre-existing registry (METC: 2022-3555). All D-OCT scans were obtained at the outpatient dermatology clinic of Maastricht University Medical Center+ (MUMC+) using a 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). All scanned lesions were histopathologically examined by a dermatopathologist blinded to D-OCT scans and D-OCT assessment.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

D-OCT scanned patients; This diagnostic cohort study will include patients (18+ years) who underwent a biopsy and D-OCT scan for lesions suspect for BCC skin cancer. Patient data was retrieved from a pre-existing registry (METC: 2022-3555). All D-OCT scans were obtained at the outpatient dermatology clinic of Maastricht University Medical Center+ (MUMC+) using a 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). All scanned lesions were histopathologically examined by a dermatopathologist blinded to D-OCT scans and D-OCT assessment.

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 23, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Imaging; Optical coherence tomography; Basal cell carcinoma; Non-melanoma skin cancer
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Neoplasms, Basal Cell; Carcinoma, Basal Cell
• Other Study ID Numbers: 2024-0059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD may be shared with other researchers upon reasonable request. Requests will be evaluated on a case by case manner.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No