Photon-Counting Computed Tomography-Based Urethral Visualization Without Catheterization for Radiotherapy Planning: A Prospective Pilot Study Under ANTHEM
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- quality of imaging
研究概览
简要总结
In prostate cancer radiotherapy, it is important to accurately identify and protect healthy organs near the prostate. One of these structures is the urethra, the tube that carries urine from the bladder out of the body. If the urethra receives too much radiation, patients may experience urinary side effects.
Current CT scans used for treatment planning do not clearly show the urethra unless a urinary catheter is inserted. While a catheter can improve visibility, it may cause discomfort, increase the risk of infection, and slightly change the natural position of the urethra. MRI scans can also help visualize the urethra, but they are not always available and may not fit easily into all treatment workflows.
Photon-counting CT (PCCT) is a new type of CT scanner that produces higher-quality images with better detail. This technology may allow doctors to see the urethra without using a catheter.
The purpose of this pilot study is to investigate whether PCCT can reliably visualize the urethra in prostate cancer patients without the need for catheter insertion. If successful, this approach could make treatment planning more comfortable and less invasive while helping doctors better protect healthy tissues during radiotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer candidate to radiotherapy
- •Written informed consent.
- •Eligibility for urethral catheter placement according to institutional practice
排除标准
- •Active or suspected urinary tract infection.
- •Known urethral stricture or recent urethral surgery
- •Contraindication to catheter placement.
结局指标
主要结局
quality of imaging
时间窗: Day of TC acquisition
Quantitative quality of prostatic urethra contouring on non-catheter photon-counting CT, assessed using spatial overlap and boundary agreement metrics, specifically the Dice similarity coefficient (DSC) and the 95th percentile Hausdorff distance (HD95), with corresponding confidence intervals.
次要结局
- evaluate inter-observer agreement of urethral contours generated on non-catheter PCCT(immediately after TC acquisition)
- compare non-catheter urethral contours with catheter-based reference contours(immediately after TC acquisition)
- assess contouring confidence and contouring time across different PCCT reconstruction approaches(immediately after TC acquisition)
- explore segmental urethral visualization along its anatomical course.(immediately after TC acquisition)
- Quantitative contour-derived parameters(immediately after TC acquisition)