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

NCT06273722 | Not Yet Recruiting

• 1 other identifier: 2024-0059
• Study Type: observational
• Target: 424
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Basal Cell Carcinoma; Optical Coherence Tomography

Keywords

Basal cell carcinoma; Optical coherence tomography; Imaging; Non-melanoma skin cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Diagnostic accuracy for BCC subtyping on D-OCT assessment

  Measured before December 31st 2024

• Diagnostic value of vascular structures and patterns

  Measured before December 31st 2024

Study Arms (1)

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

Interventions

Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner DEVICE

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).

D-OCT scanned patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patient unable to sign informed consent.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Tom Wolswijk, MD MSc

CONTACT

+31(0)43- 387 7295; tom.wolswijk@mumc.nl

Klara Mosterd, MD PhD

CONTACT

+31(0)43- 387 7295

Study Design

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

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: November 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: October 26, 2024

Record last verified: 2024-10