title: Study protocol for a prospective, non-controlled, multicentre clinical study to evaluate the diagnostic accuracy of a stepwise two-photon excited melanin fluorescence in pigmented lesions suspicious for melanoma (FLIMMA study).
abstract: Non-invasive, nanosecond, stepwise two-photon laser excitation of skin tissue was shown to induce melanin fluorescence spectra that allow for the differentiation of melanocytic nevi from cutaneous melanoma.
  
  
  
  This prospective, non-controlled, multicentre clinical study is performed to evaluate the diagnostic performance of the stepwise two-photon excited melanin fluorescence in the detection of cutaneous melanoma. The comparator will be the histopathological diagnosis. A total of 620 pigmented skin lesions suspicious for melanoma and intended for excision will be enrolled.
  
  
  
  Ethics approval was provided by the local ethics committees of the medical faculties of the University of Tuebingen, Heidelberg and Berlin.
  
  
  
  The FLIMMA study NCT02425475.
authors.affiliation: Department of Dermatology, University of Heidelberg, Germany.
authors.forename: Christine
authors.initials: C
authors.lastname: Fink
authors.affiliation: Department of Dermatology, Charité Berlin, Berlin, Germany.
authors.forename: Maja
authors.initials: M
authors.lastname: Hofmann
authors.affiliation: Department of Dermatology, Charité Berlin, Berlin, Germany.
authors.forename: Agata
authors.initials: A
authors.lastname: Jagoda
authors.affiliation: Department of Dermatology, University of Tübingen, Tübingen, Germany.
authors.forename: Iris
authors.initials: I
authors.lastname: Spaenkuch
authors.affiliation: Department of Dermatology, University of Tübingen, Tübingen, Germany.
authors.forename: Andrea
authors.initials: A
authors.lastname: Forschner
authors.affiliation: Department of Dermatology, University of Tübingen, Tübingen, Germany.
authors.forename: Ioanna
authors.initials: I
authors.lastname: Tampouri
authors.affiliation: Department of Dermatology, University of Tübingen, Tübingen, Germany.
authors.forename: Diana
authors.initials: D
authors.lastname: Lomberg
authors.affiliation: Magnosco GmbH, Deuben, Germany.
authors.forename: Dieter
authors.initials: D
authors.lastname: Leupold
authors.affiliation: Department of Dermatology, University of Tübingen, Tübingen, Germany.
authors.forename: Claus
authors.initials: C
authors.lastname: Garbe
authors.affiliation: Department of Dermatology, University of Heidelberg, Germany.
authors.forename: Holger A
authors.initials: HA
authors.lastname: Haenssle
mesh_terms: D003937:Diagnosis, Differential; D005858:Germany; D006801:Humans; D008545:Melanoma / Q000175:diagnosis*; D036641:Microscopy, Fluorescence, Multiphoton / Q000379:methods*; D009508:Nevus, Pigmented / Q000175:diagnosis*; D011446:Prospective Studies; D012107:Research Design; D012867:Skin / Q000473:pathology; D012878:Skin Neoplasms / Q000175:diagnosis*; D000096142:Cutaneous Malignant Melanoma
keywords: Diagnostic; Magnosco dermatofluoroscope; Melanin fluorescence; Melanoma; Two step photon excitation