Spots Global Cancer Trial Database for FLuorescence Identification of Melanoma by a Multicenter Based Algorithm (FLIMMA)
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Trial Identification
Brief Title: FLuorescence Identification of Melanoma by a Multicenter Based Algorithm (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
Study ID: NCT02425475
Interventions
Study Description
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:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Dept. of Dermatology, Charité, Berlin, , Germany
Dept. of Dermatology, University Hospital, Heidelberg, , Germany
Dept. of Dermatology, University Hospital, Tübingen, , Germany
Contact Details
Name: Claus Garbe, MD
Affiliation: Dept. of Dermatology, University Hospital Tübingen
Role: PRINCIPAL_INVESTIGATOR
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