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

Completed

• Conditions: Moles; Melanoma
• Interventions: Device: LIMES

• Registration Number: NCT02425475
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-04-02
• Study First Submitted QC: 2015-04-20
• Study First Posted: 2015-04-24
• Primary Completion: 2016-07
• Study Completion: 2016-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mole	LIMES	Patients with suspicious moles

Primary Outcome Measures

Name	Time	Method
To determine sensitivity and specificity of the algorithm for the fluorescence diagnostics of melanoma.	7 days	The comparator and gold standard for the diagnosis will be the histopathological diagnosis of the pigmented lesions.

Secondary Outcome Measures

Name	Time	Method
To collect data for training and optimization of the diagnostic algorithm.	1 day

Trial Locations

Locations (2)

Dept. of Dermatology, University Hospital; 🇩🇪 Tübingen, Germany

Dept. of Dermatology, Charité; 🇩🇪 Berlin, Germany