Vaginal CancerVagina-ViewNCT07818850
Vagina-View Safety and Imaging Feasibility
A study testing Vagina-View (VV) device in people with Vaginal Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This prospective, single-arm feasibility study evaluates the use of the Vagina-View (VV) device to guide the placement of a multichannel applicator (MCA) during vaginal brachytherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Cancer
- What is being tested?
- Vagina-View (VV) device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2026to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Any patient with gynecological cancer who is planned to receive MRI-guided intravaginal brachytherapy with an MCA applicator.
- Able to receive and understand verbal and written information regarding study and able to give written informed consent
Who cannot join
- Patient receiving brachytherapy with a different brachytherapy device.
- Patient with contraindications to MRI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Jelena Lukovic, 416-946-4483, jelena.lukovic@uhn.ca
About this study
Official title: Vagina-View: Safety & Imaging Feasibility Compared to Standard of Care Magnetic Resonance Imaging for Treating Vaginal Cancer Using Brachytherapy
This prospective, single-arm feasibility study evaluates the use of the Vagina-View (VV) device to guide the placement of a multichannel applicator (MCA) during vaginal brachytherapy. The study aims to determine whether the device can accurately visualize vaginal mucosal tumor involvement and improve the precision of MCA placement. By reducing the need for MRI guidance, the VV device may offer a less resource-intensive approach while minimizing radiation exposure to healthy vaginal tissue and potentially reducing treatment-related side effects. VV will not be used for participants' treatment planning and delivery. Only images will be taken with VV. The primary objective is to demonstrate the feasibility and positional accuracy of using the VV device for MCA placement.
- Conditions
- Vaginal Cancer
- Being tested
- Vagina-View (VV) device
- Medical subject headings
- Vaginal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagina-View (VV) deviceDevice
Placement of the VV applicator intravaginally during MCA brachytherapy. The VV is anticipated to be in the vagina for approximately 10-15 minutes. VV placement would be repeated for imaging scans only at each fraction of MCA brachytherapy (between 3 and 5 fractions in total). VV will not be used for participants' treatment planning and delivery. Only images will be taken with VV.
| Study group | Role | What they receive |
|---|---|---|
| Vagina-View (VV) device | Experimental | Not described Receives: Device: Vagina-View (VV) device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Location of Mucosal Disease Sites Identified Using the Vagina-View Grid Coordinate System
Vaginal mucosal disease sites visualized with the Vagina-View (VV) device while in situ will be recorded and reported. Disease location will be documented using the VV grid coordinate system.
Measured: 1 month
Secondary outcomes (4)
Treatment device positioning versus MRI visualization
Delineation of mucosal disease visible on endoscopic imaging or in relation to the VV grid coordinates + Delineation of disease visible on MRI. Measured in mm
Measured: 1 month
Extent of disease using optical visualization versus MRI
Calculation of contour overlap using DICE coefficient
Measured: 1 month
Extent of disease using optical visualization versus MRI
Calculation of contour overlap using average difference in distance in mm
Measured: 1 month
Mean Difference in Dosimetric Planning Parameters Between Vagina-View and Standard-of-Care Brachytherapy Plans
Dosimetric metrics derived from brachytherapy treatment plans generated using the VV device and SOC MCA with MRI guidance will be reported and compared using appropriate statistical methods.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start15 Sep 2026
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818850
- Sponsor's protocol ID
- 25-6017
- Acronym
- Vagina-View
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vagina-View: Safety & Imaging Feasibility Compared to Standard of Care Magnetic Resonance Imaging for Treating Vaginal Cancer Using Brachytherapy
- ClinicalTrials.gov ID
- NCT07818850
- Acronym / sponsor ID
- Vagina-View / 25-6017
- Conditions
- Vaginal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 14 Sep 2026 (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 prospective, single-arm feasibility study evaluates the use of the Vagina-View (VV) device to guide the placement of a multichannel applicator (MCA) during vaginal brachytherapy. The study aims to determine whether the device can accurately visualize vaginal mucosal tumor involvement and improve the precision of MCA placement. By reducing the need for MRI guidance, the VV device may offer a less resource-intensive approach while minimizing radiation exposure to healthy vaginal tissue and potentially reducing treatment-related side effects. VV will not be used for participants' treatment planning and delivery. Only images will be taken with VV. The primary objective is to demonstrate the feasibility and positional accuracy of using the VV device for MCA placement.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vagina-View (VV) device | Experimental | Device: Vagina-View (VV) device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any patient with gynecological cancer who is planned to receive MRI-guided intravaginal brachytherapy with an MCA applicator.
- Able to receive and understand verbal and written information regarding study and able to give written informed consent
Key exclusion criteria (2 listed)
- Patient receiving brachytherapy with a different brachytherapy device.
- Patient with contraindications to MRI.
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 |
|---|---|---|
| Vagina-View (VV) devicePlacement of the VV applicator intravaginally during MCA brachytherapy. The VV is anticipated to be in the vagina for approximately 10-15 minutes. VV placement would be repeated for imaging scans only at each fraction of MCA brachytherapy (between 3 and 5 fractions in total). VV will not be used for participants' treatment planning and delivery. Only images will be taken with VV. | Device | Vagina-View (VV) device |
Primary outcome
Number and Location of Mucosal Disease Sites Identified Using the Vagina-View Grid Coordinate System
Time frame: 1 month
Vaginal mucosal disease sites visualized with the Vagina-View (VV) device while in situ will be recorded and reported. Disease location will be documented using the VV grid coordinate system.
4 secondary outcomes
Treatment device positioning versus MRI visualization
Time frame: 1 month
Extent of disease using optical visualization versus MRI
Time frame: 1 month
Extent of disease using optical visualization versus MRI
Time frame: 1 month
Mean Difference in Dosimetric Planning Parameters Between Vagina-View and Standard-of-Care Brachytherapy Plans
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagina-View (VV) device in people with Vaginal Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. 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 Canada. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Location of Mucosal Disease Sites Identified Using the Vagina-View Grid Coordinate System (time frame: 1 month). 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 17 Sep 2026.