Lung MRI and Allergic Broncho-pulmonary Aspergillosis in Cystic Fibrosis

Pulmonary Cystic Fibrosis Clinical Trial

— MRAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02853175
• Other study ID #: ANR-10-LABX-57
• Status: Completed
• Start date: January 2014
• Est. completion date: January 2023

Study information

• Verified date: March 2023
• Source: Hôpital Haut-Lévêque
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ABPA
• Aspergillosis
• Cystic Fibrosis
• Fibrosis
• Pulmonary Aspergillosis
• Pulmonary Cystic Fibrosis

Locations

Country	Name	City	State
France	University Hospital Bordeaux	Bordeaux	Aquitaine

Sponsors (3)

Lead Sponsor	Collaborator
Hôpital Haut Lévêque	Institut National de la Santé Et de la Recherche Médicale, France, University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of lung MRI for ABPA in CF owing to increased T1 and decreased T2 signal intensity of mucus	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	From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
Secondary	Diagnostic accuracy of quantitative measurement of central mucoid impaction signal on T1-weighted sequence and T2-weighted sequence	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
Secondary	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	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
Secondary	Diagnostic follow-up of patients ABPA status 1 year	Re-evaluation of diagnostic criteria for ABPA with up to 1-year follow-up in patients with undetermined ABPA status at initial evaluation	From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
Secondary	Diagnostic accuracy of MRI to detect ABPA in CF using various ABPA classifications	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
Secondary	Reproducibility of qualitative and quantitative imaging evaluations	To assess the intra-observer and inter-observer reproducibility of 2 readers to diagnose ABPA in CF using lung MRI	From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
Secondary	Diagnostic accuracy of morphological imaging using MRI with ultrashort echotimes	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
Secondary	Diagnostic accuracy of morphological imaging using CT with reduction of doses down to chest radiograph level	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
Secondary	Reproducibility between MRI and CT with reduction of doses down to chest radiograph level to assess structural alterations	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
Secondary	Severity of small airway and perfusion alterations using functional MR sequences	Measurement of correlations between functional MRI and disease severity	From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
Secondary	Follow-up of disease severity under treatement	Measurement of variation of MR outcomes under CF treatments	From date of inclusion until the date of final treatment, assessed up to 12 months