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

May 2, 2017 updated by: University Hospital Tuebingen

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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.
Time Frame: 7 days
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.
Time Frame: 1 day
1 day

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLIMMA-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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