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)

IntroductionNon-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 analysisThis prospective, non-controlled, multicentre clinical study i...

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Bibliographic Details
Published in:BMJ open 2016-12, Vol.6 (12), p.e012730-e012730
Main Authors: Fink, Christine, Hofmann, Maja, Jagoda, Agata, Spaenkuch, Iris, Forschner, Andrea, Tampouri, Ioanna, Lomberg, Diana, Leupold, Dieter, Garbe, Claus, Haenssle, Holger A
Format: Article
Language:English
Subjects:
Accuracy
Algorithms
Data analysis
Dermatology
Diagnosis, Differential
Germany
Humans
Informed consent
Lasers
Medical prognosis
Melanoma
Melanoma - diagnosis
Melanoma, Cutaneous Malignant
Metastasis
Microscopy, Fluorescence, Multiphoton - methods
Nevus, Pigmented - diagnosis
Patients
Prospective Studies
Recruitment
Research Design
Skin - pathology
Skin cancer
Skin Neoplasms - diagnosis
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Summary:IntroductionNon-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 analysisThis 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 disseminationEthics approval was provided by the local ethics committees of the medical faculties of the University of Tuebingen, Heidelberg and Berlin.Study registrationThe FLIMMA study NCT02425475.
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2016-012730