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Completed

NCT Number: NCT02425475

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

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 histopathologic examination by the respective histopathologist of the participating centers. The histopathologic diagnosis will serve as gold standard for subsequent evaluations of the diagnostic accuracy.

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Key information

Conditions

Melanoma Moles Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Nevus Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Dermatology, Charité, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥ 18 years of age
  • Male or female
  • Patients having pigmented lesions with suspicion of dysplastic nevus or melanoma, in whom an excision is performed in order to exclude or diagnose malignant melanoma
  • Patients who gave their written informed consent.

Exclusion criteria

  • Patients with skin type V and VI according to Fitzpatrick's scale;
  • Where there is a risk that the scanning head is torn off be-cause the patient cannot be placed at rest (e.g. due to motoric disorders like tremor, convulsions, tics, compulsive acts
  • Patients who cannot understand the patient information and provide informed consent
  • Deep dermal lesions ≥ 5 mm beneath the stratum corneum
  • Clinically or reflected-light microscopically obviously non-melanocytic lesions
  • Peri- and subungual lesions
  • Mucosal lesions
  • Lesions with trauma, erosion (superficial defect), excoriation (defect down to the basement membrane) or ulceration (deep substantial defect) on more than 50 % of the lesion area (measurements must in any case not be carried out directly on the trauma, erosion, excoriation or ulceration)
  • Tattooed lesions
  • Pregnant or breast feeding women
  • Patients suffering from albinism
  • Lesions with dominant (>50%) regression
  • Lesions which are not suitable to fix the scanning cap

Treatment and study plan

LIMES

Device

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.

Primary outcomes

  1. To determine sensitivity and specificity of the algorithm for the fluorescence diagnostics of melanoma.

    Time frame: 7 days

    The comparator and gold standard for the diagnosis will be the histopathological diagnosis of the pigmented lesions.

Secondary outcomes

  1. To collect data for training and optimization of the diagnostic algorithm.

    Time frame: 1 day

Other outcomes

  1. To assess the safety of the device and to assess the incidence of adverse events

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Charite University, Berlin, Germany
  • University Hospital Heidelberg

Registry information

Official study title

A Prospective, Non-controlled, Multicenter Clinical Study to Evaluate the Diagnostic Accuracy of the Stepwise Two Photon Excited Melanin Fluorescence of Potentially Malignant Pigmented Lesions as Compared to Histopathological Diagnosis

Acronym: FLIMMA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 24, 2015
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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