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

NCT05104099 | Completed Phase 2

• 1 other identifier: 2021-000568-31
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Keywords

Vulvar Intraepithelial Neoplasia; Vulvar High Grade Squamous Intraepithelial Lesion; Photodynamic diagnosis; Metvixia; Differentiated vulvar intraepithelial neoplasia

Outcome Measures

Primary Outcomes (1)

• Evaluation of the success of the photodynamic diagnosis

  Percentage of patients for whom the procedure successfully demonstrated high-grade vulvar intraepithelial neoplasias in fluorescence confirmed by biopsy. A patient will be considered successful if the presence or absence of fluorescence is consistent with the anatomo-pathological result, that means if her sample in the fluorescent area is positive in pathology and her sample in the non-fluorescent area is negative in anatomo-pathology. For a patient with no fluorescent labeling, the pathological results of her two samples must be negative for the patient to be considered successful. For a patient where the entire area fluoresces, the anatomo-pathological result of her two samples must be positive for the patient to be considered successful.

  14 days (+/- 4 days) after the photodiagnosis

Secondary Outcomes (5)

• Sensitivity of the photodynamic diagnosis

  14 days (+/- 4 days) after the photodiagnosis

• Specifity of the photodynamic diagnosis

  14 days (+/- 4 days) after the photodiagnosis

• Intensity of flurescence evaluation

  The day of the photo analysis with a specific software

• Tolerance evaluation

  At inclusion, after applying the cream for 3 hours, before and immediately after the blue light exposition and at and the final study visite (14 days +/- 4 after the photodiagnosis)

• Pain Evaluation

  At inclusion, 1 hour after Metvixia application, before and immediately after the blue light exposition and at and the final study visite (14 days +/- 4 after the inclusion)

Study Arms (1)

Metvixia application for Photodynamic diagnosis

EXPERIMENTAL

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

Drug: Metvixia Topical Cream

Interventions

Metvixia Topical Cream 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.

Metvixia application for Photodynamic diagnosis

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (1)

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54506, France

Location

Study Officials

• Lorraine HEJL, MD

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: November 2, 2021
• Study Start: November 29, 2021
• Primary Completion: June 27, 2024
• Study Completion: May 25, 2025
• Last Updated: July 24, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)