Clinical Trial: Lung MRI and Allergic Broncho-pulmonary Aspergillosis in Cystic Fibrosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Diagnostic Accuracy of Lung MRI to Detect Allergic Broncho-pulmonary Aspergillosis in Cystic Fibrosis

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Hôpital Haut Lévêque

Current Primary Outcome: Diagnostic accuracy of lung MRI for ABPA in CF owing to increased T1 and decreased T2 signal intensity of mucus [ Time Frame: 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


Original Primary Outcome: Diagnostic accuracy of lung MRI for ABPA in CF [ Time Frame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 24 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


Current Secondary Outcome:

  • Diagnostic accuracy of quantitative measurement of central mucoid impaction signal on T1-weighted sequence and T2-weighted sequence [ Time Frame: 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 quantitative measurement of signal from central mucoid impaction using T1-weighted and T2-weighted sequences
  • Diagnostic accuracy of hyperattenuated central mucoid impaction on chest computed tomography (CT) to detect ABPA in CF [ Time Frame: 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 hyperattenuated on chest CT
  • Diagnostic follow-up of patients ABPA status 1 year [ Time Frame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months ]
    Re-evaluation of diagnostic criteria for ABPA with up to 1-year follow-up in patients with undetermined ABPA status at initial evaluation
  • Diagnostic accuracy of MRI to detect ABPA in CF using various ABPA classifications [ Time Frame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months ]
    To assess the accuracy of lung MRI to detect ABPA in a CF patient cohort if various ABPA classification are used
  • Reproducibility of qualitative and quantitative imaging evaluations [ Time Frame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months ]
    To assess the intra-observer and inter-observer reproducibility of 2 readers to diagnose ABPA in CF using lung MRI


Original Secondary Outcome:

  • Diagnostic accuracy of quantitative measurement of central mucoid impaction signal on T1-weighted sequence and T2-weighted sequence [ Time Frame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 24 months ]
    Measurement of sensitivity, specificity, positive predictive value, negative predictive value of lung MRI to diagnose ABPA in CF, owing to the quantitative measurement of signal from central mucoid impaction using T1-weighted and T2-weighted sequences
  • Diagnostic accuracy of hyperattenuated central mucoid impaction on chest computed tomography (CT) to detect ABPA in CF [ Time Frame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 24 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 hyperattenuated on chest CT
  • Diagnostic follow-up of patients with undetermined ABPA diagnosis at first evaluation [ Time Frame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 24 months ]
    Re-evaluation of diagnostic criteria for ABPA with up to 1-year follow-up in patients with undetermined ABPA status at initial evaluation
  • Diagnostic accuracy of MRI to detect ABPA in CF using various ABPA classifications [ Time Frame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 24 months ]
    To assess the accuracy of lung MRI to detect ABPA in a CF patient cohort if various ABPA classification are used
  • Reproducibility of qualitative and quantitative imaging evaluations [ Time Frame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 24 months ]
    To assess the intra-observer and inter-observer reproducibility of 2 readers to diagnose ABPA in CF using lung MRI


Information By: Hôpital Haut-Lévêque

Dates:
Date Received: July 26, 2016
Date Started: January 2014
Date Completion: February 2017
Last Updated: January 9, 2017
Last Verified: January 2017