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RECRUITING
NCT07818850
NA

Vagina-View Safety and Imaging Feasibility

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

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.

Official title: Vagina-View: Safety & Imaging Feasibility Compared to Standard of Care Magnetic Resonance Imaging for Treating Vaginal Cancer Using Brachytherapy

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-09-15

Completion Date

2028-12-30

Last Updated

2026-09-17

Healthy Volunteers

No

Conditions

Interventions

DEVICE

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.

Locations (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada