Lung MRI and Allergic Broncho-pulmonary Aspergillosis in Cystic Fibrosis (MRAB)

Hôpital Haut Lévêque

Status: Completed

Conditions: Pulmonary Cystic Fibrosis; ABPA

Study type: Observational

Funder types: Other

Identifiers

NCT02853175

ANR-10-LABX-57

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

240 participants in 2 patient groups

Patients with both CF and ABPA

Description:

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

Description:

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)