Clinical trial

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

Name

2021-000568-31

Description

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.

Trial arms

Trial start

2021-11-29

Estimated PCD

2024-12-17

Trial end

2024-12-17

Status

Recruiting

Phase

Early phase I

Treatment

Metvixia Topical Cream

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.

Arms:

Metvixia application for Photodynamic diagnosis

Size

Primary endpoint

Evaluation of the success of the photodynamic diagnosis

14 days (+/- 4 days) after the photodiagnosis

Eligibility criteria

Inclusion Criteria: * Patient aged 18 and over, * With isolated high-grade vulvar intraepithelial neoplasia OR associated with invasive cancer proven histologically by biopsy * Naive of any vulvovaginal treatment (surgery or radiotherapy) * No metastases * WHO \<or equal to 3 * Contraception method for women of childbearing potential * Patient affiliated to the social security scheme * Patient who understood, signed and dated the information note and the * consent form, * Patient able and willing to follow all study procedures in accordance with the protocol. Exclusion Criteria: * History of hypersensitivity to the active substance methyl aminolevulinate or to any of the components of the drug (including peanut oil and refined almond oil), soybean or peanut * Ulceration or hyperpigmented lesions of the vulva * Patient with porphyria * Any previous vulvovaginal treatment (surgery or radiotherapy) * Metastatic disease * Patient undergoing treatment for any other invasive cancer * Pregnant, likely to be or breastfeeding patient * Patient deprived of liberty or under guardianship (including guardianship) * Inability to undergo medical monitoring of the trial for geographic, social or psychological reasons. * Patient already included in another therapeutic trial with an experimental molecule, * Associated pathology that may prevent the patient from receiving METVIXIA application and light exposure.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 17, 'type': 'ESTIMATED'}}

Updated at

2024-03-05

1 organization

1 product

2 indications

Organization

Institut de Cancérologie de Lorraine

Product

Metvixia

Indication

Vulvar Intraepithelial Neoplasia

Indication

High Grade Squamous Intraepithelial Lesion