Multi-modal Quantitative Imaging of the Skin
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Skin Cancer, Skin Diseases, Atopic Dermatitis, Psoriasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
DermaFlow Alpha - Multi-modal Quantitative Imaging of the Skin
Overview
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.
Detailed description
This clinical investigation aims to evaluate the feasibility of full-body multi-modal imaging for screening, monitoring and diagnostic support purposes in primary care, by assessing accuracy of body measurements and sensitivity and correlation to disease. The performance in detection of skin cancer, peripheral arterial disease, Raynaud's phenomenon and dermatological conditions are within the scope of this investigation.
The multi-modal technology is based on camera systems, which can capture high-resolution 2D and 3D color images (visible spectrum) and thermal images (infrared spectrum). The appearance, shape, color, etc. and topography of lesions is captured by the color 2D camera of the system and can thus be inspected / quantified. Thermal images are used to capture thermal gradients which may be indicative of microcirculatory changes. The 3D camera is used to ensure that 2D color data and thermal data can be geometrically aligned, thus being able to compare characteristics of the two data types from the very same skin segment / lesion. Furthermore, it enables geometrical measurements of the lesions.
The participants mainly consist of a prospective primary care population, that undergo an investigation at a primary care visit. Full-body images (front and back) of all participants are captured during the visit. Participants receive a questionnaire to fill in on-site, where they state whether they have/have had any of the diseases and conditions part of the investigation. In some subjects, body measurements (circumference and distance) will be acquired manually as part of the primary care flow. Repeated yearly measurements may be performed in subjects who are interested.
Primary outcome measures
- Sensitivity for detection of lesions requiring excision in comparison to visual inspection [Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.]
- Difference in body metrics between full-body 3D photography and traditional measurements [Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.]
- Sensitivity in detection of dermatological conditions with 2D images from full-body photography [Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.]
- Sensitivity in detection of new or significantly changed lesions, from macroscopic images using 2D and 3D full-body photography. [Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.]
- Correlation between thermal gradient in hands and/or feet with diagnosis of peripheral arterial disease or Raynaud's phenomenon [Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.]
Secondary outcome measures (3)
- Thermal gradient of inflammatory area compared to surrounding skin to detect presence of psoriasis arthritis [Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.]
- Association between thermal profile/local gradient and presence of inflammatory skin conditions. [Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.]
- Identification of potential cancerous lesions by assessment of thermal profile of suspected lesions [Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- Patients not able to keep balance, while standing up with closed eyes, without any aid
- Claustrophobic patients
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Sweden · 3 centers
- Atrium Health Care Centre — Stockholm
- Neko Health Centre Regeringsgatan — Stockholm
- Neko Health Centre Sibyllegatan — Stockholm
Identifiers
NCT: NCT06989216 · SKN-P2-CIP-220905