Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial Neoplasia
- Conditions
- Differentiated Vulvar Intraepithelial NeoplasiaVulvar Intraepithelial NeoplasiaVulvar High Grade Squamous Intraepithelial Lesion
- Interventions
- Registration Number
- NCT05104099
- Lead Sponsor
- Institut de Cancérologie de Lorraine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 17
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Metvixia application for Photodynamic diagnosis Metvixia Topical Cream Patients who benefit Metvixia application to the vulva to realize fluorescence guided biopsies (Photodynamic diagnosis).
- Primary Outcome Measures
Name Time Method Evaluation of the success of the photodynamic diagnosis 14 days (+/- 4 days) after the photodiagnosis 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.
- Secondary Outcome Measures
Name Time Method Sensitivity of the photodynamic diagnosis 14 days (+/- 4 days) after the photodiagnosis The sensitivity will correspond to the number of fluorescent zones among the positive zones in anatomopathology.
Specifity of the photodynamic diagnosis 14 days (+/- 4 days) after the photodiagnosis The specificity will correspond to the number of non-fluorescent zones among the negative zones in anatomo-pathology.
Intensity of flurescence evaluation The day of the photo analysis with a specific software The fluorescence intensity will be measured by the signal to noise ratio, also called SNR (Signal to Noise Ratio) on photographie
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) The tolerance of the application will be assessed by the number of grade 3 to 5 toxicity. The toxicity will be evaluated using the CTCAE v5 scale (Common Terminology for Adverse Events). The different grade on this scale is 1 to 5 (1 correspond to a asymptomatic or mild symptome, 2 to moderate toxicity, 3 to severe or medically significant but not immediately life-threatening toxicity, 4 to life-threatening consequences or urgent intervention indicated and 5 to the death related to the toxicity.
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) Pain will be assessed using a numerical scale from 0 to 10 (0 corresponds to no pain and 10 to maximum pain)
Trial Locations
- Locations (1)
Institut de Cancerologie de Lorraine
🇫🇷Vandœuvre-lès-Nancy, France