ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 17 for:    "Allergic bronchopulmonary aspergillosis"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02853175
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : August 9, 2017
Sponsor:
Collaborators:
University Hospital, Bordeaux
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Hôpital Haut Lévêque, Hôpital Haut-Lévêque

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.

Condition or disease
Pulmonary Cystic Fibrosis ABPA

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.


Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Diagnostic Accuracy of Lung MRI to Detect Allergic Broncho-pulmonary Aspergillosis in Cystic Fibrosis
Study Start Date : January 2014
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017


Group/Cohort
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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Diagnostic accuracy of hyperattenuated central mucoid impaction on chest computed tomography (CT) to detect ABPA in CF [ 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

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients routinely followed-up for cystic fibrosis from chilhood to adulthood.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853175


Locations
France
University Hospital Bordeaux
Bordeaux, Aquitaine, France, 33000
Sponsors and Collaborators
Hôpital Haut Lévêque
University Hospital, Bordeaux
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Study Director: François Laurent, MD University Bordeaux Hospital

Responsible Party: Hôpital Haut Lévêque, MD-PhD, Hôpital Haut-Lévêque
ClinicalTrials.gov Identifier: NCT02853175     History of Changes
Other Study ID Numbers: ANR-10-LABX-57
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Aspergillosis, Allergic Bronchopulmonary
Fibrosis
Cystic Fibrosis
Aspergillosis
Pulmonary Aspergillosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Respiratory Hypersensitivity
Respiratory Tract Infections
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs