- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02853175
Lung MRI and Allergic Broncho-pulmonary Aspergillosis in Cystic Fibrosis (MRAB)
Diagnostic Accuracy of Lung MRI to Detect Allergic Broncho-pulmonary Aspergillosis in Cystic Fibrosis
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aquitaine
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Bordeaux, Aquitaine, France, 33000
- University Hospital Bordeaux
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Patients with both CF and ABPA
Patients with both cystic fibrosis and allergic broncho-pulmonary aspergillosis (ABPA). The diagnosis of ABPA (Gold Standard) rely on routine dosage of total immunoglobulin E (IgE), specific to Aspergillus IgE, specific to aspergillus Immunoglobulin G, eosinophilia on blood cell count, and imaging (infiltrate, mucoid impaction, central bronchiectasis) |
Patients with CF and no ABPA
Patients with both cystic fibrosis and no allergic broncho-pulmonary aspergillosis (ABPA). The diagnosis of ABPA (Gold Standard) rely on routine dosage of total immunoglobulin E (IgE), specific to Aspergillus IgE, specific to aspergillus Immunoglobulin G, eosinophilia on blood cell count, and imaging (infiltrate, mucoid impaction, central bronchiectasis) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
|
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
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
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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
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
|
From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
|
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
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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
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
|
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
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
|
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
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
|
From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
|
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
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Measurement of correlations between functional MRI and disease severity
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From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
|
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
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From date of inclusion until the date of final treatment, assessed up to 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: François Laurent, MD, University Bordeaux Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Infant, Newborn, Diseases
- Genetic Diseases, Inborn
- Bacterial Infections and Mycoses
- Respiratory Hypersensitivity
- Hypersensitivity
- Mycoses
- Pancreatic Diseases
- Lung Diseases, Fungal
- Fibrosis
- Cystic Fibrosis
- Aspergillosis
- Pulmonary Aspergillosis
- Aspergillosis, Allergic Bronchopulmonary
Other Study ID Numbers
- ANR-10-LABX-57
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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