Clinical trial NCT02853175: Lung MRI and Allergic Broncho-pulmonary Aspergillosis in Cystic Fibrosis
Official title: Diagnostic Accuracy of Lung MRI to Detect Allergic Broncho-pulmonary Aspergillosis in Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Cystic Fibrosis
ABPA
Lead sponsor: Hôpital Haut-Lévêque
Sponsor class: OTHER
Collaborators: name: University Hospital, Bordeaux
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2016-08-02
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients routinely followed-up for cystic fibrosis from chilhood to adulthood.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy of lung MRI for ABPA in CF owing to increased T1 and decreased T2 signal intensity of mucus
timeFrame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
Secondary outcomes:
measure: Diagnostic accuracy of quantitative measurement of central mucoid impaction signal on T1-weighted sequence and T2-weighted sequence
timeFrame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
measure: 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
timeFrame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
measure: Diagnostic follow-up of patients ABPA status 1 year
timeFrame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
measure: Diagnostic accuracy of MRI to detect ABPA in CF using various ABPA classifications
timeFrame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
measure: Reproducibility of qualitative and quantitative imaging evaluations
timeFrame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
measure: Diagnostic accuracy of morphological imaging using MRI with ultrashort echotimes
timeFrame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
measure: Diagnostic accuracy of morphological imaging using CT with reduction of doses down to chest radiograph level
timeFrame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
measure: Reproducibility between MRI and CT with reduction of doses down to chest radiograph level to assess structural alterations
timeFrame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
measure: Severity of small airway and perfusion alterations using functional MR sequences
timeFrame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
measure: Follow-up of disease severity under treatement
timeFrame: From date of inclusion until the date of final treatment, assessed up to 12 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital Bordeaux
state: Aquitaine
Study officials:
affiliation: University Bordeaux Hospital
name: François Laurent, MD
role: STUDY_DIRECTOR
References: