Evaluation for Benign and Malignant Pulmonary Ground-glass Nodules Based on MRI Dynamic Contrast Enhanced Imaging
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- Volume transfer constant (Ktrans)
研究概览
简要总结
Computed tomography (CT) is critical for the diagnosis of lung nodules as well as for therapeutic management. Repeated CT examinations will 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. Magnetic Resonance Imagery (MRI) with ultrashort echo time (UTE) pulse sequences with high signal-to-noise and spatial resolution is a promising alternative for lung nodules imaging.The purpose of the study is to evaluate the value of dynamic contrast-enhanced MR imaging (DCE-MRI) to discriminate of malignant from benign lesions.
详细描述
Computed tomography (CT) is critical for the diagnosis of lung nodules as well as for therapeutic management. Repeated CT examinations will 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. Magnetic Resonance Imagery (MRI) with ultrashort echo time (UTE) pulse sequences with high signal-to-noise and spatial resolution is a promising alternative for lung nodules imaging.The purpose of the study is to evaluate the value of DCE-MRI to discriminate of malignant from benign lesions.In this study, the investigators are going to validate the efficacy of the DCE-MRI for diagnosing early lung cancer by comparing results of the pre-surgery MRI imaging with the post-surgery pathology.
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
- •Ground-glass pulmonary nodules found by CT scan
- •Plan to accept surgery or puncture due to the pulmonary nodules
- •Absence of treatment such as chemotherapy or radiotherapy and biopsy
- •Adequate renal function to tolerate intravenous gadolinium
- •Agree to sign informed consent
- •Able to lie still during DCE-MRI
排除标准
- •Fail to understand or agree to sign informed consent
- •Implanted pacemaker or cardiac defibrillator
- •Contraindications to undergoing MRI
- •Uncontrolled intercurrent illness
- •Pregnant or breastfeeding
结局指标
主要结局
Volume transfer constant (Ktrans)
时间窗: 12 months
Pharmacokinetic parameters will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.
the fractional volume of extravascular extracellular space of the target tissue (ve)
时间窗: 12 months
Pharmacokinetic parameters will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.
the rate constant (kep)
时间窗: 12 months
Pharmacokinetic parameters will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.
次要结局
未报告次要终点
研究者
Lili Cao
investigator
Qianfoshan Hospital