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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
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.
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
RECRUITINGNumber 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.
Time frame: 1 month
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
Time frame: 1 month
Extent of disease using optical visualization versus MRI
Calculation of contour overlap using DICE coefficient
Time frame: 1 month
Extent of disease using optical visualization versus MRI
Calculation of contour overlap using average difference in distance in mm
Time frame: 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.
Time frame: 1 month
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