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

CompletedOBSERVATIONAL
Enrollment

500

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

July 31, 2016

Study Completion Date

December 31, 2016

Conditions
MelanomaMoles
Interventions
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.

Trial Locations (3)

10117

Dept. of Dermatology, Charité, Berlin

69120

Dept. of Dermatology, University Hospital, Heidelberg

72076

Dept. of Dermatology, University Hospital, Tübingen

All Listed Sponsors
collaborator

University Hospital Heidelberg

OTHER

collaborator

Charite University, Berlin, Germany

OTHER

lead

University Hospital Tuebingen

OTHER

NCT02425475 - FLuorescence Identification of Melanoma by a Multicenter Based Algorithm (FLIMMA) | Biotech Hunter | Biotech Hunter