Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma in Situ

Squamous Intraepithelial Lesions of the Cervix

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Squamous Cell

Cervical Intraepithelial Neoplasia

Central Nervous System Depressants

All Drugs and Chemicals

Dermatologic Agents

Anesthetics

Aminolevulinic Acid

Xenon

Methyl 5-aminolevulinate

Photosensitizing Agents

Patients who benefit Metvixia application to the vulva to realize fluorescence guided biopsies (Photodynamic diagnosis).

Metvixia is applied with a spatula, in a thick layer, to clinically visible lesions and all over the vulva. After applying the cream, the area will be covered with a bandage which should remain in place for 3 hours. After 3 hours of application, the bandage and the cream will be carefully removed. The application area will be cleaned and then immediately exposed to a continuous spectrum of light at a wavelength of 405 nm by a xenon lamp.

The most fluorescent areas will be identified. Then in white light, the practitioner will perform at least two biopsies under non-topical local anesthesia in the area of application of Metvixia®: one in the fluorescent area and one in the non-fluorescent area.

If there is no fluorescent labeling, two samples will be taken from two different non-fluorescent areas. In the event that all the zone is fluorescent , two samples will be taken from two different fluorescent zones.

Metvixia Topical Cream

Naoual Boujedaini, PhD

Priscillia TOSTI

BOUJEDAINI Naoual, PhD

Lorraine HEJL, MD

This study is a single-center propsective clinical trial to assess the ability of fluorescence techniques to mark high-grade vulvar intraepithelial neoplasias including high-grade vulvar squamous intraepithelial lesions and differentiated vulvar intraepithelial neoplasias following 3 hours Metvixia application.

Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial Neoplasia

Evaluation of the Ability of PpIX Fluorescence to Mark High-grade Vulvar Intraepithelial Neoplasia Following the Methyl Aminolevulinate (Metvixia®) Application

Percentage of patients for whom the procedure successfully demonstrated high-grade vulvar intraepithelial neoplasias in fluorescence confirmed by biopsy.

A patient will be considered successful if the presence or absence of fluorescence is consistent with the anatomo-pathological result, that means if her sample in the fluorescent area is positive in pathology and her sample in the non-fluorescent area is negative in anatomo-pathology.

For a patient with no fluorescent labeling, the pathological results of her two samples must be negative for the patient to be considered successful. For a patient where the entire area fluoresces, the anatomo-pathological result of her two samples must be positive for the patient to be considered successful.

The sensitivity will correspond to the number of fluorescent zones among the positive zones in anatomopathology.

The specificity will correspond to the number of non-fluorescent zones among the negative zones in anatomo-pathology.

The fluorescence intensity will be measured by the signal to noise ratio, also called SNR (Signal to Noise Ratio) on photographie

The tolerance of the application will be assessed by the number of grade 3 to 5 toxicity. The toxicity will be evaluated using the CTCAE v5 scale (Common Terminology for Adverse Events). The different grade on this scale is 1 to 5 (1 correspond to a asymptomatic or mild symptome, 2 to moderate toxicity, 3 to severe or medically significant but not immediately life-threatening toxicity, 4 to life-threatening consequences or urgent intervention indicated and 5 to the death related to the toxicity.

Pain will be assessed using a numerical scale from 0 to 10 (0 corresponds to no pain and 10 to maximum pain)

Institut de Cancérologie de Lorraine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial Neoplasia	NCT05104099	Vulvar Intraepi... Vulvar High Gra... Differentiated ...	Metvixia Topica...	18 Years -	Institut de Cancérologie de Lorraine
Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial Neoplasia	NCT05104099	Vulvar Intraepi... Vulvar High Gra... Differentiated ...	Metvixia Topica...	18 Years -	Institut de Cancérologie de Lorraine

Spots Global Cancer Trial Database for metvixia

Every month we try and update this database with for metvixia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for metvixia

Every month we try and update this database with for metvixia cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for metvixia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.