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

NCT ID: NCT05104099

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-29
• Study Completion Date: 2025-05-25

Brief Summary

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.

Conditions

Vulvar Intraepithelial Neoplasia; Vulvar High Grade Squamous Intraepithelial Lesion; Differentiated Vulvar Intraepithelial Neoplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Metvixia application for Photodynamic diagnosis

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

Group Type: EXPERIMENTAL

Metvixia Topical Cream

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut de Cancérologie de Lorraine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorraine HEJL, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de Lorraine

Locations

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, , France

Countries

France

Other Identifiers

2021-000568-31

Identifier Type: -

Identifier Source: org_study_id