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

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

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.

Study Overview

• Status: Completed
• Conditions: Melanoma; Moles
• Intervention / Treatment: Device: LIMES

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Dept. of Dermatology, Charité
  • Heidelberg, Germany, 69120
    • Dept. of Dermatology, University Hospital
  • Tübingen, Germany, 72076
    • Dept. of Dermatology, University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This study evaluates patients with pigmented lesions, which are excised in order to exclude or diagnose cutaneous melanoma.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Mole; Patients with suspicious moles

Device: LIMES; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine sensitivity and specificity of the algorithm for the fluorescence diagnostics of melanoma.	The comparator and gold standard for the diagnosis will be the histopathological diagnosis of the pigmented lesions.	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
To collect data for training and optimization of the diagnostic algorithm.	1 day

Other Outcome Measures

Outcome Measure	Time Frame
To assess the safety of the device and to assess the incidence of adverse events	7 days

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: Charite University, Berlin, Germany; University Hospital Heidelberg
• Investigators: Principal Investigator: Claus Garbe, MD, Dept. of Dermatology, University Hospital Tübingen

Publications and helpful links

General Publications

• Hofmann MA, Keim U, Jagoda A, Forschner A, Fink C, Spankuch I, Tampouri I, Eigentler T, Weide B, Haenssle HA, Garbe C. Dermatofluoroscopy diagnostics in different pigmented skin lesions: Strengths and weaknesses. J Dtsch Dermatol Ges. 2020 Jul;18(7):682-690. doi: 10.1111/ddg.14163. Epub 2020 Jul 12.
• Fink C, Hofmann M, Jagoda A, Spaenkuch I, Forschner A, Tampouri I, Lomberg D, Leupold D, Garbe C, Haenssle HA. 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). BMJ Open. 2016 Dec 19;6(12):e012730. doi: 10.1136/bmjopen-2016-012730.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 2, 2015
• First Submitted That Met QC Criteria: April 20, 2015
• First Posted (Estimate): April 24, 2015

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Dermoscopy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: FLIMMA-01