Clinical trial · Interventional
Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial Neoplasia
Evaluation of the Ability of PpIX Fluorescence to Mark High-grade Vulvar Intraepithelial Neoplasia Following the Methyl Aminolevulinate (Metvixia®) Application
NCT05104099CI-TRIAL-00092535PhotodiVINcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Differentiated Vulvar Intraepithelial Neoplasia | Vulvar Intraepithelial Neoplasia, HPV-Independent | ALIAS | 0.90 |
| Vulvar High Grade Squamous Intraepithelial Lesion | High Grade Vulvar Squamous Intraepithelial Lesion | ALIAS | 0.90 |
| Vulvar Intraepithelial Neoplasia | Vulvar Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metvixia Topical Cream | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Metvixia application for Photodynamic diagnosis
- description
- Patients who benefit Metvixia application to the vulva to realize fluorescence guided biopsies (Photodynamic diagnosis).
- interventionNames
- Drug: Metvixia Topical Cream
Primary outcomes (1)
- measure
- Evaluation of the success of the photodynamic diagnosis
- timeFrame
- 14 days (+/- 4 days) after the photodiagnosis
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.