Assessment of Lung Perfusion in Patients With Chronic Obstructive Pulmonary Disease Using FD MRI (FD-COPD)
Non-contrast-enhanced Perfusion Imaging of the Lung Using Fourier Decomposition Magnetic Resonance Imaging (FD MRI): Assessment of Feasibility in Patients With COPD in Correlation With Perfusion Scintigraphy, SPECT/CT and DCE MRI
研究概览
地位
条件
详细说明
In the recent years a novel method for functional lung imaging called Fourier decomposition MRI (FD MRI) has been introduced that allows for simultaneous assessment of regional lung perfusion and ventilation-related information without exposure to ionizing radiation or administration of intravenous or inhalational contrast agent.
In this project, the investigators plan to investigate whether Fourier decomposition (FD) MRI is able to provide similar clinical information on regional lung perfusion as the standard methods SPECT/CT and DCE MRI in patients with COPD. As MRI in patients with COPD is particularly challenging due to the rarefication of lung parenchyma, the FD MRI technique will be combined with an ultra-fast Steady-State Free Precession (ufSSFP) acquisition method for improved signal efficiency. The investigators ultimate goal is to provide a mean to predict and monitor the outcome of different therapies, such as medication, valves and surgery in COPD patients without requiring ionizing radiation or administration of contrast agents.
In the framework of this study, 30 patients with COPD will be enrolled prospectively. The study participants will be recruited by the clinic for thoracic surgery at the University Hospital Basel among all patients undergoing lung perfusion scintigraphy with SPECT/CT for surgery planning. Each participant will undergo one MRI examination of 30 min containing non-contrast-enhanced (FD MRI) and contrast-enhanced (DCE MRI) imaging studies of regional lung perfusion.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Basel、瑞士、4058
- University of Basel Hospital, Clinic of Radiology and Nuclear Medicine
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
The study participants will be recruited by the department of thoracic surgery at the University Hospital Basel among all patients who undergo Perfusion scintigraphy and SPECT/CT of the lung with 99mTc-MAA for one of the following clinical indications (of note: this selection of patients does per se exclude pregnant women):
- Preoperative assessment of regional lung perfusion before video-assisted lung volume resection (VATS-LVRS) in patients with COPD.
- Preoperative assessment of regional lung perfusion before segmentectomy, lobectomy or pneumonectomy procedures with curative intention in NSCLC patients with concomitant COPD and reduced pulmonary function parameters (FEV1 < 80%).
描述
Inclusion Criteria:
Informed Consent as documented by signature
Exclusion Criteria:
- Known hypersensitivity or allergy to Gd-based MRI contrast agents.
- Patients with cardiac pacemakers, intra cranial clips, metallic foreign bodies^or other not MRcompatible implants (e.g. pumps etc.).
- Renal failure or severely impaired kidney function (eGFR < 30 ml/min /1,73 m2)
- Known or suspected non-compliance, claustrophobia.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- Epilepsy.
- Age <18 years.
- Previous enrolment into the current study.
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
学习计划
研究是如何设计的?
设计细节
- 观测模型:病例对照
- 时间观点:预期
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Relative perfusion
大体时间:14 month
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Relative perfusion of individual pulmonary lobes expressed in % of total (bilateral) lung perfusion
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14 month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Image quality
大体时间:14 month
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Subjective classification by two independent readers
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14 month
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Perfusion defects
大体时间:14 month
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Inter-reader agreement concerning the presence of circumscribed perfusion defects
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14 month
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合作者和调查者
调查人员
- 首席研究员:Jens Bremerich, Prof.、Klinik für Radiologie und Nuklearmedizin, Universitätsspital Basel
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
慢性阻塞性肺病的临床试验
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Bangabandhu Sheikh Mujib Medical University, Dhaka...完全的
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Virginia Commonwealth UniversityFisher and Paykel Healthcare完全的
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University College, LondonUniversity of Cambridge; National Institute for Health Research, United Kingdom; Royal Free Hampstead...未知
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AstraZeneca完全的
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Chiesi Farmaceutici S.p.A.完全的中度至重度慢性阻塞性肺疾病 (COPD)保加利亚, 德国, 匈牙利, 波兰, 俄罗斯联邦, 英国