Multimodal Imaging of Basal Cell Carcinoma: A Usability Study
ConditionBasal Cell Carcinoma of Skin
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBispebjerg Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Adults aged 18 years or older with histologically confirmed or clinically suspected basal cell carcinoma attending the Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark, as part of their routine clinical care.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Non-invasive multimodal skin imaging
DeviceSequential 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: BCC Participants1 intervention
Trial outcomes
Primary outcomes
1
Time consumption per imaging modality
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.
Time frame
Single study visit, approximately 40 minutes per lesionSecondary outcomes
1
Patient-reported discomfort during imaging
Discomfort experienced during imaging with each modality (OCT, LC-OCT, and HFUS), measured on a scale from 0 to 5, where 0 equals no discomfort and 5 equals discomfort equivalent to that of a biopsy.
Time frame
Assessed immediately after completion of all imaging procedures at the single study visit.2
Practical feasibility of scanning across anatomical regions
Practical feasibility of scanning with each imaging device (OCT, LC-OCT, and HFUS) across different anatomical regions including face, scalp, trunk, and extremities, rated as simple, challenging, or complex.
Time frame
Assessed immediately after completion of all imaging procedures at the single study visit.3
Image quality across anatomical regions
Image quality of each imaging device (OCT, LC-OCT, and HFUS) across different anatomical regions, rated as high, adequate, or low.
Time frame
Assessed immediately after completion of all imaging procedures at the single study visit.Other outcomes
1
Agreement between AI-assisted imaging and histopathological morphology
Overall agreement between AI-assisted imaging findings for each modality (OCT, LC-OCT, and HFUS) and histopathological morphology obtained from routine clinical biopsy or excision, recorded as yes or no.
Time frame
Assessed at histological follow-up, up to 12 weeks after the study visit.Sponsors and contacts
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Source ClinicalTrials.gov