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

NCT06788665 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 900

Last updated 2025-01-23

No results posted yet for this study

Summary

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.

Conditions

  • Melanoma (Skin Cancer)

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.

Sponsors & Collaborators

  • Vastra Gotaland Region

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2026-01-31
Completion
2026-02-28

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06788665 on ClinicalTrials.gov