Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial Neoplasia (PhotodiVIN)
Primary Purpose
Vulvar Intraepithelial Neoplasia, Vulvar High Grade Squamous Intraepithelial Lesion, Differentiated Vulvar Intraepithelial Neoplasia
Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Metvixia Topical Cream
Sponsored by
About this trial
This is an interventional diagnostic trial for Vulvar Intraepithelial Neoplasia focused on measuring Vulvar Intraepithelial Neoplasia, Vulvar High Grade Squamous Intraepithelial Lesion, Photodynamic diagnosis, Metvixia, Differentiated vulvar intraepithelial neoplasia
Eligibility 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.
Sites / Locations
- Institut de Cancerologie de LorraineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Metvixia application for Photodynamic diagnosis
Arm Description
Patients who benefit Metvixia application to the vulva to realize fluorescence guided biopsies (Photodynamic diagnosis).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Sensitivity of the photodynamic diagnosis
The sensitivity will correspond to the number of fluorescent zones among the positive zones in anatomopathology.
Specifity of the photodynamic diagnosis
The specificity will correspond to the number of non-fluorescent zones among the negative zones in anatomo-pathology.
Intensity of flurescence evaluation
The fluorescence intensity will be measured by the signal to noise ratio, also called SNR (Signal to Noise Ratio) on photographie
Tolerance evaluation
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
Pain will be assessed using a numerical scale from 0 to 10 (0 corresponds to no pain and 10 to maximum pain)
Full Information
NCT ID
NCT05104099
First Posted
September 29, 2021
Last Updated
February 28, 2023
Sponsor
Institut de Cancérologie de Lorraine
1. Study Identification
Unique Protocol Identification Number
NCT05104099
Brief Title
Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial Neoplasia
Acronym
PhotodiVIN
Official Title
Evaluation of the Ability of PpIX Fluorescence to Mark High-grade Vulvar Intraepithelial Neoplasia Following the Methyl Aminolevulinate (Metvixia®) Application
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2021 (Actual)
Primary Completion Date
December 17, 2024 (Anticipated)
Study Completion Date
December 17, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de Lorraine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Intraepithelial Neoplasia, Vulvar High Grade Squamous Intraepithelial Lesion, Differentiated Vulvar Intraepithelial Neoplasia
Keywords
Vulvar Intraepithelial Neoplasia, Vulvar High Grade Squamous Intraepithelial Lesion, Photodynamic diagnosis, Metvixia, Differentiated vulvar intraepithelial neoplasia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metvixia application for Photodynamic diagnosis
Arm Type
Experimental
Arm Description
Patients who benefit Metvixia application to the vulva to realize fluorescence guided biopsies (Photodynamic diagnosis).
Intervention Type
Drug
Intervention Name(s)
Metvixia Topical Cream
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of the success of the photodynamic diagnosis
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.
Time Frame
14 days (+/- 4 days) after the photodiagnosis
Secondary Outcome Measure Information:
Title
Sensitivity of the photodynamic diagnosis
Description
The sensitivity will correspond to the number of fluorescent zones among the positive zones in anatomopathology.
Time Frame
14 days (+/- 4 days) after the photodiagnosis
Title
Specifity of the photodynamic diagnosis
Description
The specificity will correspond to the number of non-fluorescent zones among the negative zones in anatomo-pathology.
Time Frame
14 days (+/- 4 days) after the photodiagnosis
Title
Intensity of flurescence evaluation
Description
The fluorescence intensity will be measured by the signal to noise ratio, also called SNR (Signal to Noise Ratio) on photographie
Time Frame
The day of the photo analysis with a specific software
Title
Tolerance evaluation
Description
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.
Time Frame
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)
Title
Pain Evaluation
Description
Pain will be assessed using a numerical scale from 0 to 10 (0 corresponds to no pain and 10 to maximum pain)
Time Frame
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)
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Aude HERMAN
Phone
00 33 383 598 668
Email
m.herman@nancy.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Priscillia TOSTI
Phone
00 33 383 598 657
Email
p.tosti@nancy.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Léa LEUFFLEN
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancerologie de Lorraine
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54506
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LEUFFLEN Léa, MD PhD
Phone
+33 (0)3 83 59 84 51
Email
l.leufflen@nancy.unicancer.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial Neoplasia
We'll reach out to this number within 24 hrs