Remote Assessment of OCT Scans for BCC Detection

NCT06273709 | Not Yet Recruiting

• 1 other identifier: 2023-3698
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of high-confidence BCC diagnosis with and without clinical/dermoscopic photographs

  Diagnostic accuracy of a high confidence diagnosis (confidence-score 4) will be expressed by diagnostic parameters, such as sensitivity, specificity, positive predictive value (PPV), negative predicitive value (NPV), and diagnostic odds ratios (DOR) with 95% confidence intervals. The primary outcome in this study is specificity of a high confidence diagnosis, defined as the proportion of histological non-BCC lesions that are classified as non-BCC on OCT.

  Measured before December 31st 2024

Study Arms (2)

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.

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

OCT scans with clinical/dermoscopic photographs

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

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

Interventions

Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner 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; OCT scans without clinical/dermoscopic photographs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• Unable to sign informed consent

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Related Publications (1)

• Wolswijk T, Nelemans PJ, van Leersum F, Cruts E, Gerarda Moermans MM, Vreven L, Hillen LM, Mosterd K. The Impact of Clinical and Dermoscopic Photographs on the Diagnostic Accuracy of Remote Optical Coherence Tomography Assessment for Basal Cell Carcinoma Detection: A Comparative Diagnostic Study. Int J Dermatol. 2025 Dec 10. doi: 10.1111/ijd.70189. Online ahead of print.

  PMID: 41373084 DERIVED

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: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: March 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: December 31, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02