Feasibility Study for Ultrasound-Guided Interstitial Brachytherapy for Gynecological CancersV2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Efficacy of the 3DUS device to visualize applicators
研究概览
简要总结
Brachytherapy treatment in gynecological cancers is an essential component to delivering adequate doses of radiation to a tumour while sparing normal tissue. Interstitial and intracavitary brachytherapy is often needed in advanced or recurrent disease, in cases where intrauterine brachytherapy may not deliver the optimal outcome. Interstitial brachytherapy is based on a defined template-and-needle system, and the procedure relies on clinical examination and pre-treatment imaging to guide needle insertion. There is currently no standard image-guided process to help direct needles in the pelvis. The investigators propose a 3D ultrasound device that will provide real-time imaging for the brachytherapy procedure which will aid in avoiding needle insertion into pelvic organs and result in optimal dose coverage to the tumour.
详细描述
This is an efficacy study to optimize the use of three-dimensional ultrasound imaging for interstitial and intracavitary brachytherapy. In this study, 3DUS images will be acquired during the regular clinical procedure to assess the quality of the images, anatomical detail and location of needles. The acquired images will be analyzed post-treatment and fused with pre-treatment MRI, and post-treatment CT scans to develop a virtual simulated radiation treatment plan, and to verify the applicator positions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patients with locally advanced or recurrent gynecological malignancies who are offered interstitial or intracavitary brachytherapy treatment. These typically would include patients with primary or recurrent vaginal cancers, endometrial cancers or cervical cancers. Histologies of these cancers are typically adenocarcinomas or squamous cell carcinomas
排除标准
- •Above patients who are not offered interstitial or intracavitary brachytherapy as a treatment modality
结局指标
主要结局
Efficacy of the 3DUS device to visualize applicators
时间窗: 16 Weeks
The number of applicators identified within the 3D ultrasound image.
次要结局
- 3DUS to CT Fusion(16 Weeks)