Vulvar Intraepithelial NeoplasiaPhase 2PhotodiVINNCT05104099
Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial Neoplasia
A Phase 2 study testing Metvixia Topical Cream in people with Vulvar Intraepithelial Neoplasia and Vulvar High Grade Squamous Intraepithelial Lesion, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Intraepithelial Neoplasia, Vulvar High Grade Squamous Intraepithelial Lesion, Differentiated Vulvar Intraepithelial Neoplasia
- What is being tested?
- Metvixia Topical Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2021to 25 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Ability of PpIX Fluorescence to Mark High-grade Vulvar Intraepithelial Neoplasia Following the Methyl Aminolevulinate (Metvixia®) Application
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
- Vulvar Intraepithelial Neoplasia, Vulvar High Grade Squamous Intraepithelial Lesion, Differentiated Vulvar Intraepithelial Neoplasia
- Being tested
- Metvixia Topical Cream
- Keywords
- Vulvar Intraepithelial Neoplasia, Vulvar High Grade Squamous Intraepithelial Lesion, Photodynamic diagnosis, Metvixia, Differentiated vulvar intraepithelial neoplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Metvixia application for Photodynamic diagnosis | Experimental | Patients who benefit Metvixia application to the vulva to realize fluorescence guided biopsies (Photodynamic diagnosis). Receives: Drug: Metvixia Topical Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days (+/- 4 days) after the photodiagnosis
Secondary outcomes (5)
Sensitivity of the photodynamic diagnosis
The sensitivity will correspond to the number of fluorescent zones among the positive zones in anatomopathology.
Measured: 14 days (+/- 4 days) after the photodiagnosis
Specifity of the photodynamic diagnosis
The specificity will correspond to the number of non-fluorescent zones among the negative zones in anatomo-pathology.
Measured: 14 days (+/- 4 days) after the photodiagnosis
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
Measured: The day of the photo analysis with a specific software
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.
Measured: 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
Pain will be assessed using a numerical scale from 0 to 10 (0 corresponds to no pain and 10 to maximum pain)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start29 Nov 2021
- Primary completion27 Jun 2024
- Study completion25 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorraine HEJL, MD, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104099
- Sponsor's protocol ID
- 2021-000568-31
- Acronym
- PhotodiVIN
- Status last verified
- Jun 2024
- First submitted
- 29 Sep 2021
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ability of PpIX Fluorescence to Mark High-grade Vulvar Intraepithelial Neoplasia Following the Methyl Aminolevulinate (Metvixia®) Application
- ClinicalTrials.gov ID
- NCT05104099
- Acronym / sponsor ID
- PhotodiVIN / 2021-000568-31
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 25 May 2025 (actual)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metvixia application for Photodynamic diagnosis | Experimental | Drug: Metvixia Topical CreamPatients who benefit Metvixia application to the vulva to realize fluorescence guided biopsies (Photodynamic diagnosis). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metvixia Topical CreamMetvixia 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. | Drug | Metvixia application for Photodynamic diagnosis |
Primary outcome
Evaluation of the success of the photodynamic diagnosis
Time frame: 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.
5 secondary outcomes
Sensitivity of the photodynamic diagnosis
Time frame: 14 days (+/- 4 days) after the photodiagnosis
Specifity of the photodynamic diagnosis
Time frame: 14 days (+/- 4 days) after the photodiagnosis
Intensity of flurescence evaluation
Time frame: The day of the photo analysis with a specific software
Tolerance evaluation
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)
Pain Evaluation
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorraine HEJL, MD principal investigator
Institut de Cancérologie de Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metvixia Topical Cream in people with Vulvar Intraepithelial Neoplasia and Vulvar High Grade Squamous Intraepithelial Lesion, run by Institut de Cancérologie de Lorraine at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the success of the photodynamic diagnosis (time frame: 14 days (+/- 4 days) after the photodiagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.