About this trial
This clinical trial is about evaluating the suitability of multi-modal imaging technology, which covers virtually the entire body, to evaluate the possibility of screening and early detection of disease.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult patients that are part of the regular healthcare patient flow at the investigational sites, or as separately invited to participate in this investigation.
Patients with signed informed consent
Disqualifiers
Cognitive impairment
Patients unable to understand the oral and written study information in Swedish or English
Other severe disorder or terminal disease
Patients unable to provide an informed consent
Trial population
All patients visiting the clinical sites, seeking care, or as separately invited, are offered to participate in this investigation. This includes sub-groups of patients with suspected skin cancer, acne, rosacea, psoriasis, eczema, PAD and Raynaud's.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Sensitivity for detection of lesions requiring excision in comparison to visual inspection
Evaluate the sensitivity of detecting lesions that required excision by inspection and labelling of full-body color images acquired by full-body photography. Manual labelling of images acquired by full-body photography will be compared to ocular inspection by doctor on-site, performed as part of a standard primary care flow. An expert reviewer blinded to outcome from ocular inspection will perform the manual labelling of images.
Difference in body metrics between full-body 3D photography and traditional measurements
Evaluation of the mean difference in estimated body height, body circumference measurements and distance measurements (carotid centre - suprasternal notch, carotid centre - femoral centre and suprasternal notch - symphysis) using 3D images acquired by full-body photography compared to manual measurement using standard tape measures or height measurement tools. Difference is reported in metric units.
Sensitivity in detection of dermatological conditions with 2D images from full-body photography
Percentage of all dermatological (eczema, psoriasis, rosacea), identified by self-reported diagnosis or by ocular inspection by a healthcare professional, which can be identified by 2D images from full-body photography (remote assessment by a trained healthcare professional, blinded to the outcome). The categories of assessment conclusion may include: 1. Cleared, no presence of specified condition 2. Diagnosed with condition 3. Further diagnostic steps are needed.
Sensitivity in detection of new or significantly changed lesions, from macroscopic images using 2D and 3D full-body photography.
Sensitivity in detection of whether there are new or changed lesions on the visible parts of the body, based on a set of 2D and 3D images acquired using full-body photography. Expert reviewers with competence in lesion assessment will review images from subjects who have had no changed lesions and those who have had an excised lesion at second visit. . Images from initial and follow-up visit will be compared side-to-side. The expert reviewer will then classify, based on a collation of 2D and 3D images, into categories: 1. Significantly changed lesion 2. New lesion 3. No changed lesion.
Secondary outcomes
Thermal gradient of inflammatory area compared to surrounding skin to detect presence of psoriasis arthritis
Thermal profile (local gradient / relative temperature difference) related to presence of psoriasis arthritis, determined by self-reported diagnosis and/or diagnosis extracted from electronic health record.
Association between thermal profile/local gradient and presence of inflammatory skin conditions.
Thermal profile (absolute temperature)/local gradient (relative temperature difference) in relation to presence of inflammatory skin condition determined by self-reported diagnosis, and/or diagnosis extracted from electronic health record.
Identification of potential cancerous lesions by assessment of thermal profile of suspected lesions
Thermal gradient (relative temperature difference from thermal images between lesion and surrounding tissue) of suspected lesions that have been cleared to lesions determined to be cancerous. Lesions are pre-labelled by expert reviewer with relevant experience.
Sponsors and contacts
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