Low-dose Computer Tomography in Follow-up of High Grade Soft Tissue Sarcomas - a Prospective, Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of patients with pulmonary relapse detected by ultra-low-dose CT performed according to a pre-defined schedule
研究概览
简要总结
The goal of this interventional study is to compare sensitivity of regular chest x-ray to ultra-low-dose computed tomography to find pulmonary relapse in follow-up of soft tissue sarcoma. The main question[s] it aims to answer are:
- Is ultra-low-dose computed tomography more sensitive than regular chest x-ray to find pulmonary relapse?
- Does ultra-low-dose computed tomography detect the most fast-growing pulmonary metastases earlier than regular chest x-ray?
Participants will have seven ultra-low-dose computed tomography imagings in addition to simultaneous routine protocol of chest x-rays. Participants therefore work as their own controls.
详细描述
After primary treatment with curative intent for soft tissue sarcoma, patients fulfilling the inclusion criteria and giving informed consent are enrolled. In study protocol patients have their regular chest x-ray once in two months plus ultra-low-dose computed tomography imaging is repeated seven times during the first two years of follow-up. After two years patients without detectable metastases continue in regular follow-up program. The aims of this prospective comparative study are to investigate whether ultra-low-dose computed tomography is more accurate than chest x-ray in soft tissue sarcoma and especially whether the most fast-growing pulmonary metastases could be detected earlier.
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
- •primary high grade soft tissue sarcoma with no metastases at diagnoses or during treatment and treatment with curative intent.
排除标准
- •metastases at diagnoses or during treatment
研究组 & 干预措施
chest x-ray and ultra-low-dose computed tomography
干预措施: ultra-low-dose computed tomography (Diagnostic Test)
结局指标
主要结局
Number of patients with pulmonary relapse detected by ultra-low-dose CT performed according to a pre-defined schedule
时间窗: 2 years
Number of patients with pulmonary relapse detected by chest x-ray performed according to a pre-defined schedule
时间窗: 2 years
Number of patients with pulmonary relapse by symptoms
时间窗: 2 years
Pulmonary relapse based on patient-reported symptoms leading to positive finding in x-ray and or conventional chest CT between two control imaging rounds.
次要结局
未报告次要终点
研究者
Mika Sampo
Senior Consultant
Helsinki University Central Hospital