Lipiodol Demarcation of the Bladder Tumour in Adaptive Image-guided Radiotherapy: A Pilot Study. (Danish: Lipiodol Til Markering af blæretumoren i Forbindelse Med Adaptiv Billedvejledt strålebehandling: Et Pilotstudie.)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Is Lipiodol visible on CBCT during Radiotherapy treatment (duration)
研究概览
简要总结
Rationale: Bladder tumours are often not visible on X-ray based image-modalities during planning and treatment of Radiotherapy.
Purpose: To determine if a single contrast (Lipiodol) demarcation of the bladder tumour before treatment is feasible and visible on multiple X-ray based image-modalities during Radiotherapy.
详细描述
To exploit the potential of modern Radiotherapy (RT), it is important to localize and follow the target precisely during treatment. Since the bladder tumour can usually not be identified on conventional CT-scan, a fiducial or contrast marking system is warranted.
The iodized oil, Lipiodol is a well-known contrast media used mainly for lymphography and Hysterosalpingography. Local Lipiodol demarcation has been used for localisation of tumours in the lung, prostate and seminal vesicles visualised on Computed Tomography (CT) and fluoroscopy.
Purpose: To evaluate the feasibility of tumour demarcation using the contrast agent Lipiodol in adaptive Image-guided RT of bladder cancer. Visibility on CT, Cone-Beam CT, MRI and on-board imaging will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed primary muscle invasive transitional cell carcinoma of the Bladder. T1-4a, N0-1, M
- •Non-operable or refuse operation.
- •Eligible for curative Radiotherapy.
- •Oral and written informed consent.
- •Fertile women must have a negative pregnancy test before inclusion or use contraceptive pills or intrauterine device.
- •Ongoing beta blocker treatment is paused before Lipiodol injection.
排除标准
- •Known metabolic disorder (hyperthyroidism, goiter)
- •Allergy towards iodine.
- •Pregnancy / breast-feeding
- •Performance status ECOG > 2
研究组 & 干预措施
1
干预措施: Lipiodol demarcation of the bladder tumour (Other)
结局指标
主要结局
Is Lipiodol visible on CBCT during Radiotherapy treatment (duration)
时间窗: Daily the first week, then two times a week during Radiotherapy
Is Lipiodol demarcation visible on the planning CT (Feasibility)
时间窗: Before Radiotherapy
次要结局
未报告次要终点