Contrast-enhanced CBCT With C-arm HyperSight Technology: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of IV-contrast enhanced CBCT during image-guided radiotherapy
研究概览
简要总结
This is a single-arm prospective, feasibility study evaluating the intravenous contrast-enhanced cone beam computed tomography (IV CBCT) for image guidance during radiotherapy. Patients treated with SFRT will receive IV-contrast enhanced CT and fMRI before treatment for simulation purposes. Additionally, patients will receive mpMRI just before and IV-contrast enhanced CBCT during their second and last fraction of RT, in addition to the standard of care CBCT that is acquired for daily image-guided patient positioning. Patients will undergo both IV-contrast enhanced CBCT and treatment on the TrueBeam with HyperSight imaging capability. We hypothesize IV contrast enhanced CBCT is feasible, well-tolerated by patients and improves the visibility of the target.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Primary biopsy-proven cancer
- •Planning to undergo spatially fractionated radiation therapy
- •Able to provide informed consent
- •Willingness to participate in follow-up
- •ECOG less than or equal to 3
- •Normal creatinine (below 109mmol/L), normal eGF
排除标准
- •Unable to understand/provide consent
- •History of allergic reaction to iodinated IV contrast dye (allergy to MR contrast is not an exclusion criteria)
- •Known renal disease
- •Single kidney
- •Kidney transplant
- •Contraindication to MRI
结局指标
主要结局
Feasibility of IV-contrast enhanced CBCT during image-guided radiotherapy
时间窗: 18 Months
Feasibility of IV-contrast enhanced CBCT in visualizing tumors, vascular structures and tumour micro-environment changes during image-guided radiotherapy. The contrast-to-noise ratio, measuring the ability of an imaging modality to differentiate between various contrasts against the background noise, will be calculated and compared between CT and CBCT, and between with and without contrast acquisition.
次要结局
- Feasibility of dynamic-contrast-enhanced (DCE) imaging(18 Months)
- Image quality of full versus half (17 s) CBCT acquisition, with and without contrast enhancement(18 Months)
- Patient preferences and comfort with the use of IV CBCT during treatment(18 Months)