New diagnostic tool using fluorescence for detecting high-grade vulvar lesions
Evaluation of the Ability of PpIX Fluorescence to Mark High-grade Vulvar Intraepithelial Neoplasia Following the Methyl Aminolevulinate (Metvixia®) Application
This study is testing a new light-based method to help doctors find serious vulvar lesions in women who haven't had previous treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 17 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institut de Cancérologie de Lorraine Academic / other |
| Locations | 1 site (Vandœuvre-lès-Nancy) |
| Trial ID | NCT05104099 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a novel fluorescence technique to identify high-grade vulvar intraepithelial neoplasias, including high-grade vulvar squamous intraepithelial lesions and differentiated vulvar intraepithelial neoplasias. Participants will receive a topical application of Metvixia cream, followed by a 3-hour observation period to assess the effectiveness of the fluorescence marking. The study is conducted at a single center, focusing on patients who have not undergone prior vulvovaginal treatments. The goal is to improve diagnostic accuracy for these conditions.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and over with isolated high-grade vulvar intraepithelial neoplasia or associated invasive cancer, who have not received prior vulvovaginal treatments.
Not a fit: Patients with a history of hypersensitivity to Metvixia or its components, those with ulcerated lesions, or those who have undergone previous vulvovaginal treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the early detection and management of high-grade vulvar lesions, potentially improving patient outcomes.
How similar studies have performed: While fluorescence techniques have been explored in other contexts, this specific application for vulvar intraepithelial neoplasia detection is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Vandœuvre-lès-Nancy
- Institut de Cancerologie de Lorraine — Vandœuvre-lès-Nancy, France (Recruiting)
Study contacts
- Principal investigator: Lorraine HEJL, MD — Institut de Cancérologie de Lorraine
- Study coordinator: Naoual Boujedaini, PhD
- Email: n.boujedaini@nancy.unicancer.fr
- Phone: 00 33 383 598 668
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.