Remote Assessment of OCT Scans for BCC Detection

Maastricht University Medical Centre (MUMC)

Status: Not yet enrolling

Conditions: Basal Cell Carcinoma

Treatments: Device: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner

Study type: Observational

Funder types: Other

Identifiers

NCT06273709

2023-3698

Details and patient eligibility

About

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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18+ years of age
• Underwent OCT scan and punch biopsy for lesions suspect for BCC

Exclusion criteria

• Unable to sign informed consent

Trial design

120 participants in 2 patient groups

OCT scans without clinical/dermoscopic photographs

Description:

OCT scans will be used from a pre-existing registry. The OCT scans are made of lesions clinically suspect for BCC. All patients underwent punch biopsy conform regular care.

Treatment:

Device: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner

OCT scans with clinical/dermoscopic photographs

Description:

The same OCT scans will be used . OCT assessment is performed in conjunction with clinical and dermoscopic photographs.

Treatment:

Device: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner