Clinical trial NCT05104099: Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial Neoplasia
Official title: Evaluation of the Ability of PpIX Fluorescence to Mark High-grade Vulvar Intraepithelial Neoplasia Following the Methyl Aminolevulinate (Metvixia®) Application
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
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
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Evaluation of the success of the photodynamic diagnosis
timeFrame: 14 days (+/- 4 days) after the photodiagnosis
Secondary outcomes:
measure: Sensitivity of the photodynamic diagnosis
timeFrame: 14 days (+/- 4 days) after the photodiagnosis
measure: Specifity of the photodynamic diagnosis
timeFrame: 14 days (+/- 4 days) after the photodiagnosis
measure: Intensity of flurescence evaluation
timeFrame: The day of the photo analysis with a specific software
measure: Tolerance evaluation
timeFrame: 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)
measure: Pain Evaluation
timeFrame: 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)
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancerologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: Lorraine HEJL, MD
role: PRINCIPAL_INVESTIGATOR
References: