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临床试验/NCT02100800
NCT02100800已完成不适用

Assessment of Emphysema in COPD Patients Using 1.5T MR Imaging With Ultrashort Echo Time (UTE) Pulse Sequences

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2014年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
2
主要终点
Agreement between MRI and CT for evaluating the regional distribution of emphysema

研究概览

简要总结

Emphysema is a major pathological feature of Chronic Obstructive Pulmonary Disease (COPD). Non-invasive assessment of emphysema is a crucial issue for the phenotype and follow-up of COPD patients. Currently, CT is the method of reference to evaluate and quantify emphysema but it remains a radiation-based technique. Magnetic Resonance Imagery (MRI) with ultrashort echo time (UTE) pulse sequences is a promising non-ionizing alternative for lung imaging. Our objective is to evaluate emphysema in COPD patients using CT and MR-UTE, and to test the agreement between both techniques.

详细描述

COPD is a major public health problem and is pathologically characterized by lung emphysema and bronchial remodeling. Emphysema is defined as an irreversible destruction of alveolar walls and subsequent enlargement of air spaces. New targeted therapies against emphysema are currently developed, thereby stressing the need for non-invasive tools aimed at quantifying emphysema. Multi-slice computed tomography (CT) is the method of reference to quantify emphysema but involves ionizing radiation, thus limiting the possibility of long-term follow-up. MRI is a non-ionizing 3D imaging technique; however, lung MRI is technically challenging with the result that it is currently not used in routine practice. Indeed, both low proton density and susceptibility effects lead to a very low signal intensity derived from lung parenchyma. Recently, pulse sequences with ultrashort echo time (UTE) have been implemented by the use of half radio-frequency excitations and radial projection reconstruction. These UTE sequences make it theoretically possible to retrieve more signal from the lung parenchyma. We aim at using 3D T1-weighted UTE pulse sequences on a 1.5T magnet (Avanto dot, Siemens) in COPD patients in order to distinguish normal lung from emphysematous areas. Thirty COPD patients and 10 volunteers are expected to take part in the study. All will benefit from Pulmonary Functional Testing (PFT), CT and MRI. Our strategy will consist in quantifying pulmonary emphysema using MRI and CT in those subjects, testing for correlations between MR and CT measurements and assessing the reproducibility of emphysema quantification using MRI. Our objective is to demonstrate that MR-UTE pulse sequence at 1.5T is accurate and reproducible in evaluating and quantifying pulmonary emphysema.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female aged more than 40 years.
  • COPD group: patients with diagnosis of COPD at distance (minimum 4 weeks) from any acute exacerbation; staging 1-4 according to 2010 GOLD guidelines. PFTs and chest CT-scan should be available within a maximum of 30 days before inclusion.
  • Control group: subjects without any chronic symptoms such as cough or expectoration (St-Georges symptoms scoring < 5%), with normal chest CT-scans performed in the pretherapeutic work-up of extrapulmonary cancers within a maximum of 30 days before inclusion. These subjects will be age- and sex-matched with COPD patients.
  • With a written informed consent and health insurance.

排除标准

  • Subjects without any social security or health insurance.
  • History of asthma, lung fibrosis, pulmonary hypertension or cystic fibrosis.
  • Pregnancy.
  • Any respiratory treatment for control subjects.
  • MRI contraindications: Magnetically activated implanted devices (cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants), metal inside the eye or the brain (aneurysm clip, ocular foreign body), cardiac valvular prosthesis (Starr-Edwards pre-6000), subject with claustrophobia.

结局指标

主要结局

Agreement between MRI and CT for evaluating the regional distribution of emphysema

时间窗: During MRI and CT, Day one

MRI and CT evaluation of regional distribution of emphysema will be assessed by 2 blind radiologists. Agreement between both evaluation will be assessed during statistical analyses after study completion

次要结局

  • MR emphysema reproductibility scoring over the time(During MRI, Day one)
  • Comparison of MR emphysema scoring and lung signal values between COPD and controls(During MRI, Day one)
  • Comparison of MR emphysema scoring between different GOLD stages(During MRI, Day one)
  • Correlation between MR emphysema scoring and PFT obstructive indexes (FEV1, FEV1/FVC, DEMM25-75)(During MRI, Day one)
  • Correlation between emphysema scoring extracted from CT and MR images(During MRI and CT, Day one)
  • Agreement between MRI and CT for evaluating the presence of emphysema(During MRI and CT, Day one)
  • Comparison of signal-to-noise and contrast-to-noise ratios of lung parenchyma measured using UTE MRI and classical pulse sequences, as well as image quality assessed using a 4-point scale.(During MRI, Day one)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

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