Integrated 3D X-ray and Ultrasound Guided Radiation Therapy of Soft Tissue Targets
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Participants Able to Have the Ultrasound Probe Attached During the Entire Treatment Course
研究概览
简要总结
This clinical trial studies if kilo-voltage cone beam computed tomography (KV-CBCT) and ultrasound imaging works in guiding radiation therapy in patients with prostate, liver, or pancreatic cancer. Computer systems, such as KV-CBCT and ultrasound imaging, allow doctors to create a 3-dimensional picture of the tumor may help in planning radiation therapy and may result in more tumor cells being killed.
详细描述
PRIMARY OBJECTIVES:
I. To investigate the feasibility of combining on-board cone beam computed tomography (CBCT) with ultrasound imaging to overcome the shortcomings of CBCT or ultrasound imaging alone for imaging guided radiotherapy delivery.
OUTLINE:
Patients undergo ultrasound imaging prior to and during radiation therapy. Patients also undergo kilo-voltage cone beam computed tomography prior to radiation therapy.
Update (2021/02/04): Removed secondary outcome "Incidence of Adverse Events Related to the Ultrasound Probe". Per PI: Study initially intended to involve a non-FDA approved probe for use with liver patients but removed this section.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have either 1) cancer involving the liver by biopsy or radiographic criteria, or 2) prostate cancer by biopsy, with the intent of undergoing definitive dose radiation therapy to targets within the liver, or prostate. Patients with prostatectomy receiving post-operative radiotherapy are also eligible.
- •Karnofsky performance status (PS) ≥ 70
- •Subjects must have the ability to understand and the willingness to sign a written informational form
排除标准
- •Patients with uncontrolled inter-current illness or psychiatric illness/social situations that would limit compliance with study requirements
结局指标
主要结局
Number of Participants Able to Have the Ultrasound Probe Attached During the Entire Treatment Course
时间窗: Up to 1 year
Proportion of participants able to have the ultrasound probe attached during the entire treatment course
Percentage of Ultrasound Images Which Are Clinically Adequate for Treatment Set-up
时间窗: Up to 1 year
Percentage of ultrasound images which are clinically adequate for treatment set-up in the judgment of the treating physician
Percent of Patients Whose Plan Quality Was Not Not Affected in the Presence of the Ultrasound Probe
时间窗: Up to 1 year
Quality of plans for patients not affected in the presence of the ultrasound probe, defined as no more than a 2% decrease in tumor coverage, and also no more than a 2% increase in the dose to the most critical normal tissue for that tumor location
次要结局
未报告次要终点