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

PHASE2CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

November 29, 2021

Primary Completion Date

June 27, 2024

Study Completion Date

May 25, 2025

Conditions
Vulvar Intraepithelial NeoplasiaVulvar High Grade Squamous Intraepithelial LesionDifferentiated Vulvar Intraepithelial Neoplasia
Interventions
DRUG

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."

Trial Locations (1)

54506

Institut de Cancerologie de Lorraine, Vandœuvre-lès-Nancy

All Listed Sponsors
lead

Institut de Cancérologie de Lorraine

OTHER

NCT05104099 - Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial Neoplasia | Biotech Hunter | Biotech Hunter