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Cystic FibrosisCFMR-lungNCT03357562

MR Imaging of Lung in the Follow-up Assessment of Cystic Fibrosis

A study testing lung MRI in people with Cystic Fibrosis, run by University Hospital, Bordeaux at 11 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The aim of the study is to assess the diagnostic sensitivity of MRI to detect changes in Helbich-Bhalla scoring over time in patients with cystic fibrosis Read more about this study

Who is it for?
Ages 8 years and older
Conditions the study is for
Cystic Fibrosis
What is being tested?
lung MRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
11 sitesFrance
Study dates
5 May 2018to 6 Mar 2025
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 8 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • male or female children (age ≥ 8 y.o) and adult patient with a diagnosis of cystic fibrosis provided by genetic and swear test older than 8 years. Subgroups of patients will be defined according to:
  • age: younger or older 18y.o. We expect around 50% in different subgroups. In case of, we reach 50% in one of these groups, patient recruitment will continue for both groups until the expected number of patients in the study is reached.
  • brand name of magnet: Siemens, General Electric or Philips
  • new drugs use: association Ivacaftor/lumicaftor (OrkambiØ) or Ivacaftor only (Kalydeco Ø) ) We expect approximately 20% to 50% of patients treated
  • Informed consent provided to the patient or/and to legal representative for adults and to parents for the children
  • Patient concerned by articles L 1121-6, L 1121-7, and L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent) if the expected benefit for such persons justifies the foreseeable risk incurred

Who cannot join

  • patients without any social security or health insurance
  • pregnant women
  • Patients with previous pulmonary transplantation or planned for transplantation in the year following inclusion
  • MRI contraindications:

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

France11 sites

  • University Hospital of Bordeaux

    Bordeaux, 33000

  • University Hospital of Bordeaux

    Bordeaux, 33076

  • Hôpital Henri Mondor

    Créteil, 94010

  • CHRU de Grenoble

    Grenoble, 38043

  • CHRU de Lille

    Lille, 59000

  • Hopital Nord

    Marseille, 13385

  • Hopital Universitaire de la Timone

    Marseille, 13385

  • Fondation Lenval

    Nice, 06200

  • Hôpital Armand-Trousseau

    Paris, 75012

  • Hôpital Necker Enfant Malades

    Paris, 75015

  • CHRU Bretonneau-Tours

    Tours, 37044

Other trials in France

About this study

The aim of the study is to assess the diagnostic sensitivity of MRI to detect changes in Helbich-Bhalla scoring over time in patients with cystic fibrosis

Read the detailed description

Cystic fibrosis (CF) is caused by the cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation and represents one of the most frequent and lethal inherited disease in Caucasian. However, thanks to better treatments that slow down the progression of pulmonary disease, the median life expectancy has reached 41 years and there are nowadays more CF patients older than 18-year-old than younger. Chronic lung disease is the main manifestation and represents more than 90% of CF morbidity and mortality. However, there is a need for biomarkers more sensitive than clinical and functional findings for a personalized management of patients. Computed tomography (CT), owing to its high spatial resolution and contrast, is the standard of reference in imaging for depicting lung structural alterations. But CT is an ionizing technique, rising concern in cancer risk associated to cumulated radiation dose. To date, Magnetic Resonance Imaging (MRI) is a radiation-free technique which has been demonstrated to add meaningful functional information that cannot be reached using CT. Recent advances in 3-dimensional ultra-short echo time (3D-UTE) imaging have been shown promising to improve lung MR imaging quality. A clear delineation between airway wall and lumen was obtained, thanks to submillimeter voxel size, enabling readers to estimate both bronchial thickening and dilatation with very good concordance with CT, independently from the magnitude of score. The combination of pulse sequence may rather benefit from the potential of MRI to get more complete insight into inflammatory processes by combining several contrasts, as compared to other ionizing methods. Novel MR methods have been shown promising in assessing lung changes with high resolution and therefore could be proposed instead of CT for radiation- free repeated, life-long follow-up

Conditions
Cystic Fibrosis
Being tested
lung MRI
Keywords
Cystic fibrosis, CT, MRI, radiation dose, contrast agent
Medical subject headings
Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lung MRIDevice

    lung MRI without contrast injection

Study groups in NCT03357562
Study groupRoleWhat they receive
lung MRIExperimentallung MRI without contrast injection
Receives: Device: lung MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity of MRI to detect lung changes

    deterioration or improvement measured by the Helbich-Bhalla scoring with CT as gold standard

    Measured: Month 36

Secondary outcomes (11)

  1. Sensitivity of MRI to Helbich-Bhalla scoring change

    Sensitivity of MRI to Helbich-Bhalla scoring change in various subgroups of patients according to age, centers and MR scan manufacturers, and new treatment drug use (Ivacaftor/lumicaftor: Orkambi Ø or Ivacaftor : Kalydeco Ø ) from CT and MR examinations

    Measured: Month 0 and Month 36

  2. CT / MR concordance

    Concordance between CT and MR in amplitude of Helbich-Bhalla scoring variations at M0 and M36

    Measured: Month 0 and Month 36

  3. Sensitivity of the 3D-UTE MR sequence

    Sensitivity of the 3D-UTE MR sequence alone to detect change in Helbich-Bhalla scoring as compared to CT performed at M0 and M36

    Measured: Month 0 and Month 36

  4. Imaging quality of the 3D-UTE MR

    using a likert scale

    Measured: Month 0, Month 12, Month 24 and Month 36

  5. Correlation between a specific Helbich-Bhalla MR score and the amplitude of change

    Correlation between a specific Helbich-Bhalla MR score with clinical and functional data, and concordance with the amplitude of change between M0 and M36

    Measured: Month 0 and Month 36

  6. Accuracy of a lung MR protocol

    Accuracy of a lung MR protocol including T1-weighted and T2-weighted sequences to diagnose allergic broncho-pulmonary aspergillosis (ABPA) in CF patients

    Measured: Month 0 and Month 36

  7. Reproducibility in detecting lung structural abnormality

    MR and CT reproducibility in detecting lung structural abnormality at the segmental level

    Measured: Month 0 and Month 36

  8. Reproducibility in overall Helbich-Bhalla scoring

    MR and CT reproducibility in overall Helbich-Bhalla scoring

    Measured: Month 0 and Month 36

  9. Correlations between Helbich-Bhalla scoring and clinical questionnaire

    Correlations between Helbich-Bhalla scoring measured with MRI and CT and clinical questionnaire

    Measured: Month 0 and Month 36

  10. Correlations between Helbich-Bhalla scoring and exacerbation rate

    Correlations between Helbich-Bhalla scoring measured with MRI and CT and exacerbation rate

    Measured: Month 0 and Month 36

  11. Correlations between Helbich-Bhalla scoring and clinical pulmonary functional test

    Correlations between Helbich-Bhalla scoring measured with MRI and CT and clinical pulmonary functional test

    Measured: Month 0 and Month 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2017
  2. Study start5 May 2018
  3. Primary completion6 Mar 2025
  4. Study completion6 Mar 2025

Why it stopped: Target number of inclusion not reached

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03357562
Sponsor's protocol ID
CHUBX 2016/28
Other IDs
2017-A00764-49
Acronym
CFMR-lung
Status last verified
Mar 2025
First submitted
15 Nov 2017
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing lung MRI in people with Cystic Fibrosis, run by University Hospital, Bordeaux at 11 sites 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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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 was stopped early (reason given: Target number of inclusion not reached). Results are not available in the source record.

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?

Sensitivity of MRI to detect lung changes (time frame: Month 36). 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 NCT03357562.

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 9 Jun 2026.

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