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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)

Introduction 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. - Methods and analysis This prospective, non-controlled, multicentre clinical st...

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Main Authors: Müller-Christmann, Christine (Author) , Hofmann, Maja (Author) , Jagoda, Agata (Author) , Spaenkuch, Iris (Author) , Forschner, Andrea (Author) , Tampouri, Ioanna (Author) , Lomberg, Diana (Author) , Leupold, Dieter (Author) , Garbe, Claus (Author) , Hänßle, Holger (Author)
Format: Article (Journal)
Language:English
Published: 19 December 2016
In: BMJ open
Year: 2016, Volume: 6, Issue: 12
ISSN:2044-6055
DOI:10.1136/bmjopen-2016-012730
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1136/bmjopen-2016-012730
Verlag, lizenzpflichtig, Volltext: https://bmjopen.bmj.com/content/6/12/e012730
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Author Notes:Christine Fink, Maja Hofmann, Agata Jagoda, Iris Spaenkuch, Andrea Forschner, Ioanna Tampouri, Diana Lomberg, Dieter Leupold, Claus Garbe, Holger A. Haenssle
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Summary:Introduction 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. - Methods and analysis 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 and dissemination Ethics approval was provided by the local ethics committees of the medical faculties of the University of Tuebingen, Heidelberg and Berlin. - Study registration The FLIMMA study NCT02425475.
Item Description:Gesehen am 18.05.2020
Physical Description:Online Resource
ISSN:2044-6055
DOI:10.1136/bmjopen-2016-012730

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