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

Melanoma Clinical Trial

— FLIMMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425475
• Other study ID #: FLIMMA-01
• Status: Completed
• Phase: N/A
• First received: April 2, 2015
• Last updated: May 2, 2017
• Start date: August 2014
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Moles

Intervention

Device:
• LIMES
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.

Locations

Country	Name	City	State
Germany	Dept. of Dermatology, Charité	Berlin
Germany	Dept. of Dermatology, University Hospital	Heidelberg
Germany	Dept. of Dermatology, University Hospital	Tübingen

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Charite University, Berlin, Germany, University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To assess the safety of the device and to assess the incidence of adverse events		7 days
Primary	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	To collect data for training and optimization of the diagnostic algorithm.		1 day