Lung MRI and Allergic Broncho-pulmonary Aspergillosis in Cystic Fibrosis

NCT02853175 | Completed DMC

• 1 other identifier: ANR-10-LABX-57
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Cystic Fibrosis; ABPA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Diagnostic accuracy of quantitative measurement of central mucoid impaction signal on T1-weighted sequence and T2-weighted sequence

  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

  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

  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

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

• Reproducibility of qualitative and quantitative imaging evaluations

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

Study Arms (2)

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)

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients routinely followed-up for cystic fibrosis from chilhood to adulthood.

You may qualify if:

• 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
• 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.

Sponsors & Collaborators

• Hôpital Haut Lévêque: lead
• University Hospital, Bordeaux: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

University Hospital Bordeaux

Bordeaux, Aquitaine, 33000, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• François Laurent, MD

  University Bordeaux Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD-PhD

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 2, 2016
• Study Start: January 1, 2014
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)