Vagina-View Safety and Imaging Feasibility
NCT07818850
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.
Eligibility
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.
Conditions2
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NCT07818850