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RECRUITING Not applicable ClinicalTrials.gov

Vagina-View Safety and Imaging Feasibility

Sponsor: University Health Network, Toronto • ClinicalTrials.gov ID: NCT07818850

Registry updated: 2026-09-17
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Description

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.

Interventions

  • Vagina-View (VV) device (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.

Eligibility criteria

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.

Conditions

Vaginal Cancer

Locations

  • Princess Margaret Cancer Centre — Toronto, Ontario, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record