Multimodal Imaging of Basal Cell Carcinoma: A Usability Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Non-invasive multimodal skin imaging: Sequential non-invasive imaging of basal cell carcinoma lesions using three AI-assisted imaging modalities: OCT (VivoSight Dx, Michelson Diagnostics), LC-OCT (deepLive, DAMAE Medical), and HFUS (SkinScanner, Dermus). All devices are CE-marked Class IIa medical devices used within their approved intended purpose. Each device incorporates an AI module to support image interpretation. Imaging is performed at a single study visit and is strictly observational and adjunct to standard clinical care. No tissue is removed and no therapeutic intervention is performed.

Study summary

The goal of this observational study is to evaluate the time efficiency and practical usability of three non-invasive skin imaging tools in adults (18 years and older) with basal cell carcinoma (BCC), the most common type of skin cancer. The main questions it aims to answer are:

How long does it take to perform each scan (optical coherence tomography, line-field confocal optical coherence tomography, and high-frequency ultrasound)? How comfortable is each scan for participants? How well do the imaging tools work across different areas of the body?

Participants will undergo one study visit of approximately 40 minutes, during which three non-invasive skin scans are performed on the skin lesion. Each scan uses a different imaging tool. Participants will also complete a short questionnaire about their experience. No biopsies or other invasive procedures are performed as part of the study.

Eligibility

Primary outcome measure(s)

• Time consumption per imaging modality — Single study visit, approximately 40 minutes per lesion
  Time consumption measured in minutes per patient for each modality (OCT, LC-OCT, and HFUS) and in total, recorded from the start of device set-up to the completion of image acquisition and documentation.

Trial sites (1)

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