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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| Hauptverfasser: | , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
19 December 2016
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| In: |
BMJ open
Year: 2016, Jahrgang: 6, Heft: 12 |
| ISSN: | 2044-6055 |
| DOI: | 10.1136/bmjopen-2016-012730 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1136/bmjopen-2016-012730 Verlag, lizenzpflichtig, Volltext: https://bmjopen.bmj.com/content/6/12/e012730 |
| Verfasserangaben: | Christine Fink, Maja Hofmann, Agata Jagoda, Iris Spaenkuch, Andrea Forschner, Ioanna Tampouri, Diana Lomberg, Dieter Leupold, Claus Garbe, Holger A. Haenssle |
| Zusammenfassung: | 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. |
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| Beschreibung: | Gesehen am 18.05.2020 |
| Beschreibung: | Online Resource |
| ISSN: | 2044-6055 |
| DOI: | 10.1136/bmjopen-2016-012730 |