Vaginal Cancer
Conditions
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.
Interventions
DEVICEVagina-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.
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Location of Mucosal Disease Sites Identified Using the Vagina-View Grid Coordinate System | 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
| Measure | Time frame | Description |
|---|---|---|
| Treatment device positioning versus MRI visualization | 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 |
| Extent of disease using optical visualization versus MRI | 1 month | Calculation of contour overlap using DICE coefficient |
| Mean Difference in Dosimetric Planning Parameters Between Vagina-View and Standard-of-Care Brachytherapy Plans | 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. |
Countries
Canada
Outcome results
None listed