SARCOLOWDOSE : Ultra-low Dose CT Scan and MRI in Thoracic Sarcoidosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 7
- 主要终点
- Percentage of fibrosis within the 2 lungs (reticulations with or without honeycombing) in standard CT and ULD CT to study diagnostic agreement between these techniques
研究概览
简要总结
The goal of this study is to evaluate the diagnostic agreement between, on the one hand, ultra-low dose CT and MRI with UTE pulse sequences, and on the other hand, standard CT scan, to quantify lung parenchyma patterns in thoracic sarcoidosis.
详细描述
Sarcoidosis is a chronic disease involving lung and mediastinum in more than 90% of cases. Five to 25% of thoracic sarcoidosis are complicated by a severe fibrotic lung disease. Computed tomography (CT) is critical for the diagnosis of thoracic sarcoidosis as well as for therapeutic management. Repeated CT examinations, sometimes all life long, raise the issue of the cumulative radiation dose and subsequent risk of cancer, thus pushing the need for imaging techniques using low or no radiation dose. Based upon tube voltage and current reduction as well as iterative recontsruction, ultra-low dose CT (ULD CT) allows to lower the dose up to that of a traditional chest X-ray. Magnetic resonance imaging (MRI) using Ultrashort echo time (UTE) enables lung parenchyma imaging with high signal-to-noise and spatial resolution.
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
- •Patients aged 18 years or more
- •Diagnosed with thoracic sarcoidosis according to ATS/ERS/WASOG 1999 criteria, with stages 2, 3 or 4, or lung function significantly impaired
- •For whom a chest CT examination without contrast medium is indicated in the normal follow-up of the disease
- •covered by social security
- •having received information about the study and having given written informed consent
排除标准
- •Pregnant woman
- •Adult person unable to give consent
- •Patient in exclusion period du to another protocol
结局指标
主要结局
Percentage of fibrosis within the 2 lungs (reticulations with or without honeycombing) in standard CT and ULD CT to study diagnostic agreement between these techniques
时间窗: Day 0
次要结局
- Drent score adapted from Oberstein with ULD CT(Day 0)
- Main pulmonary artery to ascending aorta diameter ratio measured with UTE MRI(Day 0)
- Image quality of lung parenchyma assessed qualitatively using ULD CT(Day 0)
- Percentage of pulmonary nodules within the 2 lungs in standard CT and ULD CT(Day 0)
- Percentage of ground-glass opacity within the 2 lungs in standard CT and ULD CT(Day 0)
- Main pulmonary artery to ascending aorta diameter ratio measured with ULD CT(Day 0)
- Percentage of ground-glass opacity within the 2 lungs in standard CT and UTE MRI(Day 0)
- Drent score adapted from Oberstein with UTE MRI(Day 0)
- Percentage of fibrosis measured by 2 readers for ULD CT(Day 0)
- Percentage of consolidation within the 2 lungs in standard CT and ULD CT(Day 0)
- Image quality of lung parenchyma assessed quantitatively using ULD CT(Day 0)
- Percentage of fibrosis measured by 2 readers for UTE MRI(Day 0)
- Percentage of pulmonary nodules within the 2 lungs in standard CT and UTE MRI(Day 0)
- Score of tolerance for MRI examinations(Day 0)
- Percentage of fibrosis within the 2 lungs in standard CT and UTE MRI(Day 0)
- Percentage of consolidation within the 2 lungs in standard CT and UTE MRI(Day 0)
- Main pulmonary artery to ascending aorta diameter ratio measured with standard CT(Day 0)
- Drent score adapted from Oberstein with standard CT(Day 0)
- Image quality of lung parenchyma assessed quantitatively using UTE MRI(Day 0)
- Image quality of lung parenchyma assessed qualitatively using standard CT(Day 0)
- Percentage of fibrosis measured by 2 readers for standard CT(Day 0)
- Image quality of lung parenchyma assessed quantitatively using standard CT(Day 0)
- Image quality of lung parenchyma assessed qualitatively using UTE MRI(Day 0)
- Score of tolerance for CT examinations(Day 0)