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

Institut de Cancérologie de Lorraine

Status and phase: Completed; Phase 2

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

Treatments: Drug: Metvixia Topical Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT05104099

2021-000568-31

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Metvixia application for Photodynamic diagnosis

Experimental group

Description:

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

Treatment:

Drug: Metvixia Topical Cream