Pulmonary Cystic FibrosisMRABNCT02853175
Lung MRI and Allergic Broncho-pulmonary Aspergillosis in Cystic Fibrosis
An observational study of Pulmonary Cystic Fibrosis and ABPA, run by Hôpital Haut Lévêque at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Pulmonary Cystic Fibrosis, ABPA
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients routinely followed-up for cystic fibrosis from chilhood to adulthood.
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of Lung MRI to Detect Allergic Broncho-pulmonary Aspergillosis in Cystic Fibrosis
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.
Read the 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.
- Conditions
- Pulmonary Cystic Fibrosis, ABPA
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
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
Measured: 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
Re-evaluation of diagnostic criteria for ABPA with up to 1-year follow-up in patients with undetermined ABPA status at initial evaluation
Measured: 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
To assess the accuracy of lung MRI to detect ABPA in a CF patient cohort if various ABPA classification are used
Measured: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
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
Measured: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
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
Measured: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
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
Measured: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
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
Measured: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
Severity of small airway and perfusion alterations using functional MR sequences
Measurement of correlations between functional MRI and disease severity
Measured: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
Follow-up of disease severity under treatement
Measurement of variation of MR outcomes under CF treatments
Measured: From date of inclusion until the date of final treatment, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2023
- Study completionJan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Haut Lévêque
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bordeaux, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor-investigator, Hôpital Haut Lévêque, Hôpital Haut-Lévêque
- Investigators
- François Laurent, MD, Study director, University Bordeaux Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853175
- Sponsor's protocol ID
- ANR-10-LABX-57
- Acronym
- MRAB
- Status last verified
- Mar 2023
- First submitted
- 26 Jul 2016
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Lung MRI to Detect Allergic Broncho-pulmonary Aspergillosis in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02853175
- Acronym / sponsor ID
- MRAB / ANR-10-LABX-57
- Conditions
- Pulmonary Cystic Fibrosis, ABPA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Hôpital Haut LévêqueUniversity, hospital or other
- Collaborators
- University Hospital, Bordeaux, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Jan 2014
- Primary completion
- Jan 2023 (actual)
- Study completion
- Jan 2023 (actual)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients routinely followed-up for cystic fibrosis from chilhood to adulthood.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
10 secondary outcomes
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
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
Time frame: 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
Time frame: 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
Time frame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
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
Diagnostic accuracy of morphological imaging using MRI with ultrashort echotimes
Time frame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
Diagnostic accuracy of morphological imaging using CT with reduction of doses down to chest radiograph level
Time frame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
Reproducibility between MRI and CT with reduction of doses down to chest radiograph level to assess structural alterations
Time frame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
Severity of small airway and perfusion alterations using functional MR sequences
Time frame: From date of inclusion until the date of final ABPA status diagnosis, assessed up to 12 months
Follow-up of disease severity under treatement
Time frame: From date of inclusion until the date of final treatment, assessed up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Laurent, MD study director
University Bordeaux Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Cystic Fibrosis and ABPA, run by Hôpital Haut Lévêque at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.