Investigation of the Performance of the Medical Device Dermalyser in Determining Melanoma Thickness Based on Dermoscopy Images
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
- The protocol lists: Medical Device Dermalyser.
- Who it may be relevant to
- Registry conditions: Melanoma (Skin Cancer). 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 →
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Official title
Investigation of the Performance of the Medical Device Dermalyser in Determining Melanoma Thickness Based on Dermoscopy Images - A Single-center, Non-randomized, Parallel, and Double-blinded Prospective Clinical Investigation
Overview
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.
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 i
Primary outcome measures
- Area under the curve (AUC) for discrimination between invansive and in situ melanoma for the "in distribution data set". [Time frame: From enrollment to the end of the inclusion when the images of the lesion have been obtained. This will most often be achieved on the same day as that the patient is included in the study.]
Secondary outcome measures (1)
- Sensitivity and Specificity [Time frame: From enrollment to the end of the inclusion when the images of the lesion have been obtained. This will most often be achieved on the same day as that the patient is included in the study.]
Eligibility criteria
Inclusion criteria
- Patient needs to be ≥18 years of age at inclusion
- The patient has a suspected primary melanoma where surgery is planned
- Willingness and ability to provide informed consent
Exclusion criteria
- 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.
- As per judgement by the investigator, to exclude when there are factors that may affect the quality of the photo such as when:
- Lesion with any form of modifications such as tattoos, pen markings, and/or pigments covering or surrounding skin lesions.
- 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.
- Lesions masked by an excessive amount of hair, generally found in armpits, scalp, beards or other hairy parts of the body.
- Lesions that are scarred, non-intact, injured, previously biopsied or undergone surgery. in areas that are not suitable for dermoscopy imaging.
- Individuals with skin type V and VI according to the Fitzpatrick scale (darker brown or black coloured skin)
- Patients that do not perform surgery or die before the planned surgery
- Missing or uninterpretable diagnostic data from the Department of Pathology.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Sweden · 1 center
- Department of Dermatology and Venereology Sahlgrenska University Hospital, Gröna stråket 1 — Gothenburg
Identifiers
NCT: NCT06788665 · CIV-24-06-047957