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

Launched by INSTITUT DE CANCÉROLOGIE DE LORRAINE · Oct 22, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to detect a specific type of skin condition called high-grade vulvar intraepithelial neoplasia (VIN), which can lead to cancer if not treated. The researchers want to see if using a special light technique, after applying a medication called Metvixia, can help identify these areas more effectively. The study is currently recruiting women aged 18 and older who have been diagnosed with this condition through a biopsy and have not received any prior treatment for it.

If you or someone you know is interested in participating, eligible women must not be pregnant or breastfeeding, and they should not have any history of severe allergies to the study medication or related substances. Participants can expect to apply the Metvixia cream and then undergo a procedure using fluorescence technology to see if it can accurately highlight the affected areas. It's important to note that those who are currently under other treatments or have certain medical conditions may not qualify. This trial aims to improve detection methods, which could lead to better treatment outcomes for women with this condition.

Gender

FEMALE

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.