FLuorescence Identification of Melanoma by a Multicenter Based Algorithm (FLIMMA)

Study Overview
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Brief Summary
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All patients will undergo dermoscopic diagnosis and be documented with a video image storing. The diagnosis based on dermoscopy will be immediately documented. Then, as a second diagnostic procedure, fluorescence diagnostics based on the two photon excitation from a dye-laser will be performed. The classification as non-melanoma or malignant melanoma by the medical device LIMES will also be documented immediately. Afterwards, the lesion will be excised and undergo histopathologic examination by the respective histopathologist of the participating centers. The histopathologic diagnosis will serve as gold standard for subsequent evaluations of the diagnostic accuracy.

Official Title
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A Prospective, Non-controlled, Multicenter Clinical Study to Evaluate the Diagnostic Accuracy of the Stepwise Two Photon Excited Melanin Fluorescence of Potentially Malignant Pigmented Lesions as Compared to Histopathological Diagnosis

Conditions
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Melanoma, Moles

Intervention / Treatment
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* Device: LIMES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years of age Male or female Patients having pigmented lesions with suspicion of dysplastic nevus or melanoma, in whom an excision is performed in order to exclude or diagnose malignant melanoma Patients who gave their written informed consent. Exclusion Criteria: Patients with skin type V and VI according to Fitzpatrick's scale; Where there is a risk that the scanning head is torn off be-cause the patient cannot be placed at rest (e.g. due to motoric disorders like tremor, convulsions, tics, compulsive acts Patients who cannot understand the patient information and provide informed consent Deep dermal lesions ≥ 5 mm beneath the stratum corneum Clinically or reflected-light microscopically obviously non-melanocytic lesions Peri- and subungual lesions Mucosal lesions Lesions with trauma, erosion (superficial defect), excoriation (defect down to the basement membrane) or ulceration (deep substantial defect) on more than 50 % of the lesion area (measurements must in any case not be carried out directly on the trauma, erosion, excoriation or ulceration) Tattooed lesions Pregnant or breast feeding women Patients suffering from albinism Lesions with dominant (>50%) regression Lesions which are not suitable to fix the scanning cap

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mole<br>Patients with suspicious moles | Device: LIMES<br>* All patients will undergo dermoscopic diagnosis and be documented with a video image storing. The diagnosis based on dermoscopy will be immediately documented. Then, as a second diagnostic procedure, fluorescence diagnostics based on the two photon excitation from a dye-laser will be performed. The classification as non-melanoma or malignant melanoma by the medical device LIMES will also be documented immediately. Afterwards, the lesion will be excised and undergo histo-pathologic examination by the respective histopathologist of the participating centers. The histopathologic diagnosis will serve as gold standard for subsequent evaluations of the diagnostic accuracy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine sensitivity and specificity of the algorithm for the fluorescence diagnostics of melanoma. | The comparator and gold standard for the diagnosis will be the histopathological diagnosis of the pigmented lesions. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect data for training and optimization of the diagnostic algorithm. |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dermoscopy