Diagnostic Accuracy of Lung MRI to Detect Allergic Broncho-pulmonary Aspergillosis in Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of lung MRI for ABPA in CF owing to increased T1 and decreased T2 signal intensity of mucus
研究概览
简要总结
In this diagnostic study, the aim is at evaluating the diagnostic accuracy of MRI (Magnetic Resonance Imaging) to detect allergic broncho-pulmonary aspergillosis in patients with cystic fibrosis.
详细描述
Allergic broncho-pulmonary aspergillosis (ABPA) is not rare in the context of cystic fibrosis (CF), with a prevalence reported between 2% to 16%. This complication is a diagnostic challenge for clinicians, since it is related with poorer outcome and higher worsening of the disease. Therefore, the treatment relies on corticosteroid and antifungal therapy and thus, it is important to detect with good sensitivity because CF patients are usually treated with antibiotics. However, the treatment is often difficult to be initiated because of potential secondary side effects related to diabetes mellitus, growth impairment, bone mineralisation or immunodepression. Therefore, there is a need for specific diagnostic tool to discriminate ABPA amongst other polymicrobial infection.
Lung MRI is a radiation-free imaging modality which offers the potential to combine several contrasts, in order to enable in vivo tissue characterization non-invasively. Investigators hypothesize that characterization of mucoid impaction using lung MR T1-weighted and T2-weighted contrasts may be a specific tool to diagnose ABPA in CF non invasively. Additional information on functional information related to ventilation and/or perfusion will be assessed using functional MR sequences, to assess the severity of small airway impairment. Moreover, the diagnostic value of structural alterations such as bronchiectasis, mucoid impaction and consolidation/atelectasis using either MRI with ultrashort echo times or CT using reduction of doses down to chest radiograph levels will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cystic fibrosis proven by sweat chloride and genetic tests
- •Age superior or equal to 6 year-old
- •Diagnosis of ABPA available on the basis of the criteria by Cystic Fibrosis Foundation Consensus Conference
- •No contraindication to perform MRI
- •Non-Inclusion Criteria:
- •. Age inferior to 6-year-old
- •Cystic fibrosis not proven
- •ABPA status not documented
- •MRI contraindications: Pregancy, Magnetically activated implanted devices (cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants...), metal inside the eye or the brain (aneurysm clip, ocular foreign body not compatible with MRI), cardiac valvular prothesis not compatible with MRI, subject with claustrophobia.
排除标准
- 未提供
结局指标
主要结局
Diagnostic accuracy of lung MRI for ABPA in CF owing to increased T1 and decreased T2 signal intensity of mucus
时间窗: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
Measurement of sensitivity, specificity, positive predictive value, negative predictive value of lung MRI to diagnose ABPA in CF, owing to the presence of central mucoid impactions that appear both hyperintense on T1-weighted sequence and hypointense on T2-weighted sequence
次要结局
- Diagnostic accuracy of quantitative measurement of central mucoid impaction signal on T1-weighted sequence and T2-weighted sequence(From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months)
- Diagnostic follow-up of patients ABPA status 1 year(From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months)
- Diagnostic accuracy of morphological imaging using MRI with ultrashort echotimes(From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months)
- Reproducibility between MRI and CT with reduction of doses down to chest radiograph level to assess structural alterations(From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months)
- Reproducibility of qualitative and quantitative imaging evaluations(From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months)
- Diagnostic accuracy of hyperattenuated central mucoid impaction on chest computed tomography (CT) to detect ABPA in CF, using reduction of doses down to chest radiograph level(From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months)
- Diagnostic accuracy of MRI to detect ABPA in CF using various ABPA classifications(From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months)
- Diagnostic accuracy of morphological imaging using CT with reduction of doses down to chest radiograph level(From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months)
- Follow-up of disease severity under treatement(From date of inclusion until the date of final treatment, assessed up to 12 months)
- Severity of small airway and perfusion alterations using functional MR sequences(From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months)
研究者
Hôpital Haut Lévêque
MD-PhD
Hôpital Haut-Lévêque