A Prospective Monocentric Study to Assess the Concordance of Lung MRI Compared to Chest CT Scan to Assess the Extent and Severity of Bronchial and Parenchymal Pulmonary Lesions in Adult Patients With Primary Immune Deficiency (PID): IRM vs SCANNER
试验速览
- 阶段
- 不适用
- 发起方
- Hopital Foch
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To assess the bronchial lesions
研究概览
简要总结
Currently, there is no official recommendations for the respiratory surveillance of patients with PID.However, it is recommended to perform a chest CT scan each 5 years or before any significant therapeutic change.
The methods of surveillance need to meet two contradictory imperatives:
- monitor frequently enough not to diagnose with delay an aggravation of bronchiectasis or interstitial pneumonitis, an infectious complication by a slowly growing pathogen such as a non-tuberculous mycobacterium, or lymphoid proliferation.
- do not expose these often young patients to significant irradiation by a considerable number of scans during their life. In addition, some patients with PID have increased radiosensitivity without a safe irradiation threshold having been determined.
To make thoses requirements effective, the solution is to combine radiological monitoring and absence of irradiation. Therefore, it makes sense to study whether chest scans can be replaced by MRI, non-irradiating imaging. But the question that needs to be answered is whether the information provided by the chest MRI is not inferior to that provided by the scanner.
The objective of this study is to assess the ability of MRI performed with ultrashort echo time to analyze the extent and severity of bronchial and pulmonary parenchymal lesions during the follow-up of patients with primary immunodeficiency, comparing them to those of the chest CT scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 or over
- •Adult patients with PID
- •Patients who have performed EFR (Functional Respiratory Tests) within 6 months
- •Patients who have signed a consent form
- •Patients affiliated with a Health Insurance plan.
排除标准
- •Pregnant woman
- •Contraindications to MRI:
- •Patients with magnetically activated implanted devices (cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants),
- •Patients with intraocular metal or in the brain (aneurysm clip),
- •Patients with prostheses in the thoracic position and contraindicated for MRI examination
- •Claustrophobic patients.
- •To be deprived of liberty or under guardianship.
结局指标
主要结局
To assess the bronchial lesions
时间窗: 6 montths
Analysis of the presence, the severity (cylindrical, varicose or cystic) and segmental distribution of bronchiectasis, 2. the presence and lobar distribution of hypoperfused pulmonary areas, and 3. the presence and lobar distribution of interstitial abnormality and pulmonary nodular lesions. Those three components will be independently identified by lung scanners and MRIs.
To assess the parenchymal lesions
时间窗: 6 montths
Analysis of the presence and lobar distribution of hypoperfused pulmonary areas
次要结局
- To assess the MRI results versus the scanner results(6 months)
