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NCT Number: NCT07818850

Vagina-View Safety and Imaging Feasibility

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.

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Key information

Conditions

Vaginal Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Vaginal Diseases Vaginal Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location status: Recruiting

Location contact

Jelena Lukovic

CONTACT

[email protected]

416-946-4483

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Treatment device positioning versus MRI visualization

    Time frame: 1 month

    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

  2. Extent of disease using optical visualization versus MRI

    Time frame: 1 month

    Calculation of contour overlap using DICE coefficient

  3. Extent of disease using optical visualization versus MRI

    Time frame: 1 month

    Calculation of contour overlap using average difference in distance in mm

  4. Mean Difference in Dosimetric Planning Parameters Between Vagina-View and Standard-of-Care Brachytherapy Plans

    Time frame: 1 month

    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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: Vagina-View

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 14, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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