Remote Assessment of OCT Scans for BCC Detection

Trial Title: Remote Assessment of OCT Scans for BCC Detection

NCT ID: NCT06273709

Condition: Basal Cell Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Basal Cell

Conditions: Keywords:
Basal cell carcinoma
Optical coherence tomography
Imaging
Non-melanoma skin cancer

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Device
Intervention name: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner
Description: (Michelson Diagnostics Maidstone, Kent, UK; resolution <7.5 µm lateral, <5 µm axial; depth of focus 1.0 mm; scan area 6 × 6 mm).
Arm group label: OCT scans with clinical/dermoscopic photographs
Arm group label: OCT scans without clinical/dermoscopic photographs

Summary: Basal cell carcinoma (BCC) is the most common form of cancer and entails approximately 80% of all cutaneous malignancies. This locally destructive neoplasm is commonly diagnosed by punch biopsy which is considered painful, causes procedural scarring and carries a small risk of infection and re-bleeding associated with invasive procedures. Moreover, awaiting the results of the subsequent histopathological examination causes treatment delay and can be stressful for the patient. The drawbacks of biopsy could be overcome by optical coherence tomography (OCT), a non-invasive diagnostic modality that may replace biopsy in up to 66% of patients. However, OCT assessors are scarce which hinders the implementation of OCT. This problem may be addressed by teledermatology in which remote OCT assessment by an assessor facilitates simultaneous assessment for multiple clinics. Remote OCT assessment withholds the OCT assessor from visually inspecting the lesion. But the effect of visual inspection on the diagnostic accuracy remains unknown and the question arises whether visual inspection is necessary for accurate OCT assessment. In this diagnostic case-control study we will determine whether distant OCT assessment without visual information on the lesion is non-inferior to distant OCT assessment with clinical and dermoscopic photographs (CDP-OCT).

Criteria for eligibility:

Study pop:
Included cases contain OCT scans of patients with lesions suspect for BCC. Three OCT assessors will be included in this study to assess the OCT scans with and without clinical and dermoscopic photographs.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - 18+ years of age - Underwent OCT scan and punch biopsy for lesions suspect for BCC Exclusion Criteria: - Unable to sign informed consent

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Start date: March 1, 2024

Completion date: December 31, 2024

Lead sponsor:
Agency: Maastricht University Medical Center
Agency class: Other

Source: Maastricht University Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06273709