Evaluation of the Ability of PpIX Fluorescence to Mark High-grade Vulvar Intraepithelial Neoplasia Following the Methyl Aminolevulinate (Metvixia®) Application
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Evaluation of the success of the photodynamic diagnosis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Metvixia application for Photodynamic diagnosis
Patients who benefit Metvixia application to the vulva to realize fluorescence guided biopsies (Photodynamic diagnosis).
干预措施: Metvixia Topical Cream (Drug)
结局指标
主要结局
Evaluation of the success of the photodynamic diagnosis
时间窗: 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.
次要结局
- 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))