Vagina-View: Safety & Imaging Feasibility Compared to Standard of Care Magnetic Resonance Imaging for Treating Vaginal Cancer Using Brachytherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number and Location of Mucosal Disease Sites Identified Using the Vagina-View Grid Coordinate System
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient receiving brachytherapy with a different brachytherapy device.
- •Patient with contraindications to MRI.
研究组 & 干预措施
Vagina-View (VV) device
干预措施: Vagina-View (VV) device (Device)
结局指标
主要结局
Number and Location of Mucosal Disease Sites Identified Using the Vagina-View Grid Coordinate System
时间窗: 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.
次要结局
- Mean Difference in Dosimetric Planning Parameters Between Vagina-View and Standard-of-Care Brachytherapy Plans(1 month)
- Extent of disease using optical visualization versus MRI(1 month)
- Treatment device positioning versus MRI visualization(1 month)