Skip to main content
OpenTrials
Completed

NCT Number: NCT02853175

Lung MRI and Allergic Broncho-pulmonary Aspergillosis in Cystic Fibrosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pulmonary Cystic Fibrosis ABPA Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Bordeaux

Bordeaux, Aquitaine, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

None

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

    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

  3. 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

  4. 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

  5. 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

  6. Diagnostic accuracy of morphological imaging using MRI with ultrashort echotimes

    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 structural alterations

  7. Diagnostic accuracy of morphological imaging using CT with reduction of doses down to chest radiograph level

    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 CT to diagnose ABPA in CF, owing to the presence of structural alterations

  8. Reproducibility between MRI and CT with reduction of doses down to chest radiograph level to assess structural alterations

    Time frame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months

    Measurement of agreement and concordance between MRI with ultrashort echo times and CT with reduction of doses down to chest radiograph level to assess the Bhalla score

  9. Severity of small airway and perfusion alterations using functional MR sequences

    Time frame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months

    Measurement of correlations between functional MRI and disease severity

  10. Follow-up of disease severity under treatement

    Time frame: From date of inclusion until the date of final treatment, assessed up to 12 months

    Measurement of variation of MR outcomes under CF treatments

Sponsors and collaborators

Lead sponsor

Hôpital Haut Lévêque

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • University Hospital, Bordeaux

Registry information

Official study title

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

Acronym: MRAB

Important dates

Study start
2014
Primary completion
2023
Study completion
2023
First posted
Aug 2, 2016
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.