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

• Status: Not yet recruiting
• Trial end date: 2024-11-18
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Cancérologie de Lorraine
• Treatments: Methyl 5-aminolevulinate

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- 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.