Cystic FibrosisUBD-IRMNCT04644471
Comparison Between Ultra-low-dose Computed Tomography and Lung MRI in Cystic Fibrosis
A study testing CT scanner and Lung MRI in people with Cystic Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to compare the performances of ultra-low dose computed tomography (CT) and lung magnetic resonance imaging (MRI) for morphological assessment of cystic fibrosis-related lung disease and to compare their performances to conventional low dose CT Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- CT scanner and Lung MRI
- How many people
- 185 participants
- Where
- 1 siteFrance
- Study dates
- 5 Aug 2021to 25 Jul 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 year-old
- Diagnosis of cystic fibrosis provided by genetic and swear test
- Chest CT acquisition performed as part of the standard follow-up
- Patient with social security or health insurance
- Informed consent
Who cannot join
- MRI contraindication
- Orthopnea
- Inability to hold breath for 17 seconds
- No spirometry planned the same day
- Lung transplant patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Ultra-low-dose Computed Tomography and Lung MRI for Morphological Assessment of Lung Disease in Adult Cystic Fibrosis Patients
The purpose of this study is to compare the performances of ultra-low dose computed tomography (CT) and lung magnetic resonance imaging (MRI) for morphological assessment of cystic fibrosis-related lung disease and to compare their performances to conventional low dose CT
Read the detailed description
Cystic fibrosis (CF) is a recessive autosomal disease caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that encodes for an epithelial chloride channel involved in ion and fluid transport. CF is the most common inherited disease in Caucasians and disease severity mainly depends on the degree of lung involvement, which can lead to terminal respiratory failure Disease monitoring of CF-related lung disease rely on functional assessment and complimentary morphological assessment. Conventional low-dose chest computed tomography (CT) is currently the gold standard for the morphological assessment of CF-related lung disease but ultra-low dose chest CT and high-resolution magnetic resonance imaging (MRI) of the lung using UTE sequences have been recently developed and allow important radiation reduction of radiation dose exposure. However the performances of these 2 competing imaging methods remains to be compared.
- Conditions
- Cystic Fibrosis
- Being tested
- CT scanner, Lung MRI
- Keywords
- Magnetic resonance imaging, Multidetector computed tomography
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scannerDiagnostic test
1 conventional low dose inspiratory acquisition and 1 ultra-low-dose inspiratory acquisition
Lung MRIDiagnostic test
3 UTE sequences (free breathing, inspiratory and expiratory) and 1 T2 sequence
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility of visual score between imaging modalities
Reproducibility disease severity measured by the Helbich scoring system with conventional CT as gold standard
Measured: 1 day
Secondary outcomes (3)
Intra and interobserver reproducibility of visual scores
Intra and interobserver reproducibility of the Helbich score for each imaging modality
Measured: 1 day
Correlation between visual scores and pulmonary function
Correlation between the Helbich score for each imaging modality and forced expiratory volume in 1 second (FEV1)
Measured: 1 day
Correlation between air trapping at MRI and pulmonary function test
Correlation between air trapping, measured by comparing inspiratory to expiratory MRI images, and forced expiratory volume at one second (FEV1)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start5 Aug 2021
- Primary completion25 Jul 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Marie-Pierre REVEL, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644471
- Sponsor's protocol ID
- APHP190061
- Other IDs
- 2019-A02078-49
- Acronym
- UBD-IRM
- Status last verified
- Feb 2026
- First submitted
- 5 Oct 2020
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dournes G, Grodzki D, Macey J, Girodet PO, Fayon M, Chateil JF, Montaudon M, Berger P, Laurent F. Quiet Submillimeter MR Imaging of the Lung Is Feasible with a PETRA Sequence at 1.5 T. Radiology. 2015 Jul;276(1):258-65. doi: 10.1148/radiol.15141655. Epub 2015 Mar 13.
PubMed 25768672Dournes G, Menut F, Macey J, Fayon M, Chateil JF, Salel M, Corneloup O, Montaudon M, Berger P, Laurent F. Lung morphology assessment of cystic fibrosis using MRI with ultra-short echo time at submillimeter spatial resolution. Eur Radiol. 2016 Nov;26(11):3811-3820. doi: 10.1007/s00330-016-4218-5. Epub 2016 Feb 2.
PubMed 26843010Chassagnon G, Martin C, Ben Hassen W, Freche G, Bennani S, Morel B, Revel MP. High-resolution lung MRI with Ultrashort-TE: 1.5 or 3 Tesla? Magn Reson Imaging. 2019 Sep;61:97-103. doi: 10.1016/j.mri.2019.04.015. Epub 2019 Apr 30.
PubMed 31051201Chassagnon G, Martin C, Marini R, Vakalopolou M, Regent A, Mouthon L, Paragios N, Revel MP. Use of Elastic Registration in Pulmonary MRI for the Assessment of Pulmonary Fibrosis in Patients with Systemic Sclerosis. Radiology. 2019 May;291(2):487-492. doi: 10.1148/radiol.2019182099. Epub 2019 Mar 5.
PubMed 30835186
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultra-low-dose Computed Tomography and Lung MRI for Morphological Assessment of Lung Disease in Adult Cystic Fibrosis Patients
- ClinicalTrials.gov ID
- NCT04644471
- Acronym / sponsor ID
- UBD-IRM / APHP190061
- Conditions
- Cystic Fibrosis
- Keywords
- Magnetic resonance imaging, Multidetector computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 25 Nov 2020 (actual)
- 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.
The purpose of this study is to compare the performances of ultra-low dose computed tomography (CT) and lung magnetic resonance imaging (MRI) for morphological assessment of cystic fibrosis-related lung disease and to compare their performances to conventional low dose CT
Detailed description
Cystic fibrosis (CF) is a recessive autosomal disease caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that encodes for an epithelial chloride channel involved in ion and fluid transport. CF is the most common inherited disease in Caucasians and disease severity mainly depends on the degree of lung involvement, which can lead to terminal respiratory failure Disease monitoring of CF-related lung disease rely on functional assessment and complimentary morphological assessment. Conventional low-dose chest computed tomography (CT) is currently the gold standard for the morphological assessment of CF-related lung disease but ultra-low dose chest CT and high-resolution magnetic resonance imaging (MRI) of the lung using UTE sequences have been recently developed and allow important radiation reduction of radiation dose exposure. However the performances of these 2 competing imaging methods remains to be compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 year-old
- Diagnosis of cystic fibrosis provided by genetic and swear test
- Chest CT acquisition performed as part of the standard follow-up
- Patient with social security or health insurance
- Informed consent
Key exclusion criteria (5 listed)
- MRI contraindication
- Orthopnea
- Inability to hold breath for 17 seconds
- No spirometry planned the same day
- Lung transplant patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scanner1 conventional low dose inspiratory acquisition and 1 ultra-low-dose inspiratory acquisition | Diagnostic test | – |
| Lung MRI3 UTE sequences (free breathing, inspiratory and expiratory) and 1 T2 sequence | Diagnostic test | – |
Primary outcome
Reproducibility of visual score between imaging modalities
Time frame: 1 day
Reproducibility disease severity measured by the Helbich scoring system with conventional CT as gold standard
3 secondary outcomes
Intra and interobserver reproducibility of visual scores
Time frame: 1 day
Correlation between visual scores and pulmonary function
Time frame: 1 day
Correlation between air trapping at MRI and pulmonary function test
Time frame: 1 day
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 13 Feb 2026.
- Background: PubMed 25768672Dournes G, Grodzki D, Macey J, Girodet PO, Fayon M, Chateil JF, Montaudon M, Berger P, Laurent F. Quiet Submillimeter MR Imaging of the Lung Is Feasible with a PETRA Sequence at 1.5 T. Radiology. 2015 Jul;276(1):258-65. doi: 10.1148/radiol.15141655. Epub 2015 Mar 13.
- Background: PubMed 26843010Dournes G, Menut F, Macey J, Fayon M, Chateil JF, Salel M, Corneloup O, Montaudon M, Berger P, Laurent F. Lung morphology assessment of cystic fibrosis using MRI with ultra-short echo time at submillimeter spatial resolution. Eur Radiol. 2016 Nov;26(11):3811-3820. doi: 10.1007/s00330-016-4218-5. Epub 2016 Feb 2.
- Background: PubMed 31051201Chassagnon G, Martin C, Ben Hassen W, Freche G, Bennani S, Morel B, Revel MP. High-resolution lung MRI with Ultrashort-TE: 1.5 or 3 Tesla? Magn Reson Imaging. 2019 Sep;61:97-103. doi: 10.1016/j.mri.2019.04.015. Epub 2019 Apr 30.
- Background: PubMed 30835186Chassagnon G, Martin C, Marini R, Vakalopolou M, Regent A, Mouthon L, Paragios N, Revel MP. Use of Elastic Registration in Pulmonary MRI for the Assessment of Pulmonary Fibrosis in Patients with Systemic Sclerosis. Radiology. 2019 May;291(2):487-492. doi: 10.1148/radiol.2019182099. Epub 2019 Mar 5.
- 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.
Marie-Pierre REVEL, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT scanner and Lung MRI in people with Cystic Fibrosis, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 5 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 13 Feb 2026. 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?
Reproducibility of visual score between imaging modalities (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04644471, which also lists 4 linked publications.
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 13 Feb 2026.