Multi-modal Quantitative Imaging of the Skin (DermaFlow)

HJN Sverige AB/Neko Health

Status: Enrolling

Conditions: Atopic Dermatitis; Psoriasis; Diabetic Foot; Raynaud Disease; Skin Diseases; Skin Cancer; Peripheral Arterial Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT06989216

SKN-P2-CIP-220905

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

8,000 participants in 1 patient group

patient_cohort

Description:

The study participants mainly consist of a prospective primary care 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 skin cancer and dermatological conditions.