Melanoma (Skin Cancer)
Conditions
Keywords
Screening, Body Photography, Total Body Photography, Dermoscopic Imaging Device, dermoscopy, Body skin imaging, Dysplastic Naevi, CDKN2A Mutation
Brief summary
This study aims to generate evidence on patient and dermatologist perspectives regarding two total body photography systems. Patient and clinician preferences represent key factors in healthcare decision-making. The investigation will also provide data on the time efficiency of each system in a real-world setting.
Detailed description
Novel tools utilizing artificial intelligence (AI) as total body photography (TBP) and sequential digital dermoscopy imaging (SDDI) with deep-learning algorithms are new approaches with the potential to improve the screening of melanocytic skin lesions by detecting new pigmented lesions as well as dynamic changes in existing moles. TBP with automated non-contact dermoscopy holds the potential to perform these tasks more time efficiently. Both TBP systems enable imaging of the majority of a patient's skin surface. These two systems are distinguished by their methods: the Vectra system requires manual and selective SDDI acquisition using a handheld camera, whereas the Deviskan system automatically captures SDDI for all pigmented lesions exceeding 4 mm, without direct skin contact. Patients receive audio and visual instructions through monitors to maintain specific postures as the camera moves to capture images. The investigators aim to compare the usability and limits of both devices in a real-world scenario, focusing on the patients' and doctors' preference and opinion. This is the first head-to-head comparison of these two total body photography and dermoscopic imaging devices.
Interventions
DEVICEDeviskan
Autonomous total body photography and dermoscopic imaging system Deviskan, Softwares: Devisoft, Devisual, Deviplatform, (Dermavision Solutions S. L., Figueres, Catalonia, Spain)
DEVICEVectra WB360
3D total body photography imaging system Vectra WB360, digital dermoscopic camera VISIOMED D200evo dermatoscope, DermaGraphix IntelliStudio, (Canfield Scientific Inc., Parsippany, New Jersey, USA)
OTHERStandard-of-care clinical examinations
Active control with standard-of-care clinical examinations by experienced dermatologists.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Masking description
To minimise or avoid bias, a study design with a temporary blinding procedure was selected. The investigators are temporary blinded. Firstly, the dermatologists will perform the clinical skin assessment and submit their risk assessment for the patients' pigmented skin lesions (malignant vs. benign). The investigation staff or doctoral candidate will then perform the assessments with the imaging systems. In a final step, the dermatologists will re-evaluate the same pigmented skin lesions with access to all total body photography and dermoscopic images. Investigation subjects and the investigation staff performing the imaging assessments are not blinded.
Intervention model description
A prospective, single center, comparative, observational study with paired design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Signed informed consent by the participant * Sufficient proficiency in German * At least one of the following risk criteria for melanoma: * Previous melanoma (including in situ) * Suspected melanoma * ≥ 100 common naevi * ≥ 5 dysplastic naevi * dysplastic naevus syndrome * Known CDKN2A mutation * Strong family history for melanoma (≥ first- and/or second-degree relatives)
Exclusion criteria
* Lack of informed consent * Immobility. (Patients must be able to stand without support for 30 minutes.) * Inability to follow the procedures of the investigation, including inability to follow on-screen instructions or to read (e.g. due to visual impairment or cognitive impairment) * Vulnerable Subjects * Active skin conditions that may impact the performance of TBP systems or skin cancer screenings * Cardiac pacemaker * Pregnant women (self reported, no pregnancy test planned) * Height below 150 cm or above 195 cm * Severe Claustrophobia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Questionnaire after examination | During the only study visit, immediately after examination by dermatologist and both medical devices is finished | Patients rate their perceived safety of examination with Deviskan and Vectra WB360 on a separate unnumbered visual analogue scale for each device. The scale ranges from 0 to 10, 10 indicating the highest possible perceived safety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Questionnaire after examination | During the only study visit, immediately after examination by dermatologist and both medical devices is finished | Reference points: patients rate their perceived safety after clinical examination by dermatologist alone, and after combination of clinical examination and AI-based imaging on separate unnumbered visual analogue scales for the examination by dermatologist and the combinations. The scale ranges from 0 to 10, 10 indicating the highest possible perceived safety. |
| Patient Questionnaire before examination | During the only study visit, immediately before examination by dermatologist and both medical devices is started | Topics: Height, bodyweight, age, gender, level of education, reason for examination, previous experience with TBP, perceived diagnostic potential of AI, preference regarding AI involvement in diagnostics, willingness to pay out of pocket, subjective level of worry about developing melanoma and level of tension previously to examination. Assessed using visual analogue scales, predefined multiple-choice items and open comment fields. |
| Dermatologists Questionnaire | During the only study visit, immediately after examinations and reevaluation | Questions regarding user-friendliness of medical devices, perceived thoroughness, subjective assessment of image quality, influence of TBP on clinical decision, preferred examination strategy for this patient. Assessed using visual analogue scales and predefined multiple-choice items. |
Countries
Switzerland
Contacts
CONTACTLea Habermacher
Outcome results
None listed