Remote Assessment of OCT Scans for BCC Detection

NCT ID: NCT06273709

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-12-31

Brief 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).

Conditions

Basal Cell Carcinoma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

OCT scans without clinical/dermoscopic photographs

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.

Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner

Intervention Type: DEVICE

(Michelson Diagnostics Maidstone, Kent, UK; resolution \<7.5 µm lateral, \<5 µm axial; depth of focus 1.0 mm; scan area 6 × 6 mm).

OCT scans with clinical/dermoscopic photographs

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

Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner

Intervention Type: DEVICE

(Michelson Diagnostics Maidstone, Kent, UK; resolution \<7.5 µm lateral, \<5 µm axial; depth of focus 1.0 mm; scan area 6 × 6 mm).

Interventions

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).

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Tom Wolswijk, MD MSc

Role: CONTACT

tom.wolswijk@mumc.nl

+31(0)43- 387 7295

Klara Mosterd, MD PhD

Role: CONTACT

+31(0)43- 387 7295

Other Identifiers

2023-3698

Identifier Type: -

Identifier Source: org_study_id