Investigation of the Performance of the Medical Device Dermalyser in Determining Melanoma Thickness Based on Dermoscopy Images

Study Purpose

In Sweden, approximately 9,000 Swedes are affected by melanoma annually, and each year, 500 individuals die from metastatic melanoma. The prognosis for melanoma primarily depends on the thickness of the tumor at diagnosis. Melanomas that only grow in the epidermis and have not yet grown into the dermis are called melanoma in situ or pre-melanoma. These melanomas lack the potential to spread in the body. Melanomas that grow into the dermis, on the other hand, are called invasive or malignant melanomas. Invasive melanomas have the potential to spread in the body. To improve melanoma diagnostics, a dermatoscope is used. A dermatoscope is a type of magnifying glass equipped with a strong light. Using a dermatoscope makes the structures in the epidermis and dermis clearer. Although most melanomas are relatively easy to detect, it is often difficult to determine whether melanomas are invasive or in situ based on the dermatoscopic image. Despite the fact that all suspected melanomas (regardless of melanoma depth) should be operated on, it is important to form an opinion on whether the melanoma is invasive or in situ. This decision is important because it: 1. Provides guidance on how quickly healthcare must prioritize a patient for surgery. 2. Provides guidance on the margin the surgeon chooses for the first operation. 3. Affects the information we give the patient even before the first operation. In recent years, several applications of machine learning have shown great potential in research contexts within dermatology and venereology. However, these tools have been evaluated to a very limited extent in clinical trials, which is naturally a prerequisite before they can be safely implemented in routine healthcare.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patient needs to be ≥18 years of age at inclusion. 2. The patient has a suspected primary melanoma where surgery is planned. 3. Willingness and ability to provide informed consent.

Exclusion Criteria:

1. The suspected lesion size is too small or too large to fit the white circle in the screen even after zooming in and out at its maximum. The lesion should not be < 2 mm or > 20 mm in diameter. 2. As per judgement by the investigator, to exclude when there are factors that may affect the quality of the photo such as when: 1. Lesion with any form of modifications such as tattoos, pen markings, and/or pigments covering or surrounding skin lesions. 2. Lesions located on areas such as genitalia, acral skin (foot sole or palm of the hand), mucosal surfaces (mouth, eye, nose, etc.), psoriasis or similar skin conditions. 3. Lesions masked by an excessive amount of hair, generally found in armpits, scalp, beards or other hairy parts of the body. 4. Lesions that are scarred, non-intact, injured, previously biopsied or undergone surgery. in areas that are not suitable for dermoscopy imaging. 3. Individuals with skin type V and VI according to the Fitzpatrick scale (darker brown or black coloured skin) 4. Patients that do not perform surgery or die before the planned surgery. 5. Missing or uninterpretable diagnostic data from the Department of Pathology.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06788665
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Vastra Gotaland Region
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Sweden
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma (Skin Cancer)
Arms & Interventions

Arms

: Cutaneous melanoma

Interventions

Device: - Medical Device Dermalyser

Dermalyser is an Artificial Intelligence (AI) application (app) that allows medical professionals to take pictures of cutaneous lesions with the help of a smartphone camera. A dermatoscope is connected to the smartphone camera and is used to take the digital image of cutaneous lesions with suspicion of melanoma. Based on image processing algorithms, the app does a detailed analysis of the captured cutaneous lesion. In this clinical investigation, the objective is to test the device performance in a prospective setting in patients with a suspicion of primary cutaneous melanoma, to validate the added AI component. The intended purpose of the device is not to replace the physician's assessment, but rather to assist physicians in their assessment. Consequently, the final device should be regarded as a second opinion to augment clinical decision-making. The ultimate aim is to develop a tool that may augment clinical decision-making.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Gothenburg, Sweden

Status

Address

Department of Dermatology and Venereology Sahlgrenska University Hospital, Gröna stråket 16

Gothenburg, , 413 45

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