Recruiting

Vagina-View

Sponsor:

University Health Network, Toronto

Code:

NCT07818850

Conditions

Vaginal Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vagina-View (VV) device

Study Details

Brief 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. 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

Study ID

NCT07818850

Start date

Sep 15, 2026

Status verified date

Sep, 2026

Completion date

Dec 30, 2028

Anticipated

Primary completion date

Dec 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient receiving brachytherapy with a different brachytherapy device.
  • Patient with contraindications to MRI.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Vagina-View (VV) device

Interventions

Vagina-View (VV) device

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.

Primary outcome measure

  • Number and Location of Mucosal Disease Sites Identified Using the Vagina-View Grid Coordinate System [ Time Frame: 1 month ]

Central Contacts and Locations

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Jelena Lukovic

416-946-4483jelena.lukovic@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-09-17.