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

NCT02425475 | Completed

• 1 other identifier: FLIMMA-01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Melanoma; Moles

Keywords

Dermoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  1 day

Other Outcomes (1)

• To assess the safety of the device and to assess the incidence of adverse events

  7 days

Study Arms (1)

Mole

Patients with suspicious moles

Device: LIMES

Interventions

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.

Mole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• University Hospital Heidelberg: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (3)

Dept. of Dermatology, Charité

Berlin, 10117, Germany

Location

Dept. of Dermatology, University Hospital

Heidelberg, 69120, Germany

Location

Dept. of Dermatology, University Hospital

Tübingen, 72076, Germany

Location

Related Publications (2)

• 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.

  PMID: 32657017 DERIVED

• 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.

  PMID: 27993903 DERIVED

MeSH Terms

Conditions

Melanoma; Nevus

Condition Hierarchy (Ancestors)

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

Study Officials

• Claus Garbe, MD

  Dept. of Dermatology, University Hospital Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 24, 2015
• Study Start: August 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

DE (3)