Trials Sponsors Conditions Drugs Pricing

Conditions

Differentiated Vulvar Intraepithelial Neoplasia Vulvar High Grade Squamous Intraepithelial Lesion Vulvar Intraepithelial Neoplasia

Keywords

Vulvar Intraepithelial NeoplasiaVulvar High Grade Squamous Intraepithelial LesionPhotodynamic diagnosisMetvixiaDifferentiated vulvar intraepithelial neoplasia

Outcome Measures

Primary Outcomes (1)

Evaluation of the success of the photodynamic diagnosis
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.
14 days (+/- 4 days) after the photodiagnosis

Secondary Outcomes (5)

Sensitivity of the photodynamic diagnosis
14 days (+/- 4 days) after the photodiagnosis

Study Arms (1)

Metvixia application for Photodynamic diagnosis

EXPERIMENTAL

Patients who benefit Metvixia application to the vulva to realize fluorescence guided biopsies (Photodynamic diagnosis).

Drug: Metvixia Topical Cream

Interventions

Metvixia Topical CreamDrug

Metvixia is applied with a spatula, in a thick layer, to clinically visible lesions and all over the vulva. After applying the cream, the area will be covered with a bandage which should remain in place for 3 hours. After 3 hours of application, the bandage and the cream will be carefully removed. The application area will be cleaned and then immediately exposed to a continuous spectrum of light at a wavelength of 405 nm by a xenon lamp. The most fluorescent areas will be identified. Then in white light, the practitioner will perform at least two biopsies under non-topical local anesthesia in the area of application of Metvixia®: one in the fluorescent area and one in the non-fluorescent area. If there is no fluorescent labeling, two samples will be taken from two different non-fluorescent areas. In the event that all the zone is fluorescent , two samples will be taken from two different fluorescent zones.

Metvixia application for Photodynamic diagnosis

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexfemale(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient aged 18 and over,
With isolated high-grade vulvar intraepithelial neoplasia OR associated with invasive cancer proven histologically by biopsy

Sponsors & Collaborators

Institut de Cancérologie de Lorraine
Otherlead

Study Sites (1)

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54506, France

Study Officials

Lorraine HEJL, MD
Institut de Cancérologie de Lorraine
PRINCIPAL INVESTIGATOR

Enrollment

17 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 29, 2021

First Posted

November 2, 2021

Study Start

November 29, 2021

Actual (reported)

Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial Neoplasia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Metvixia application for Photodynamic diagnosis

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Metvixia application for Photodynamic diagnosis

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations