Cystic FibrosisMucoIRMNCT02449785
Assessment of Cystic Fibrosis Lung Involvement With UTE Pulse Sequences
A study testing MR measurements of lung morphological changes in cystic fibrosis (Avanto dot, Siemens) and CT measurements of lung morphological changes in cystic fibrosis in people with Cystic Fibrosis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Non-invasive assessment of lung involvement is a crucial issue for the follow-up of cystic fibrosis patients. Currently, CT is the method of reference to evaluate and quantify the lung morphological changes in cystic fibrosis adults but it remains a radiation-based technique. 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?
- MR measurements of lung morphological changes in cystic fibrosis (Avanto dot, Siemens) and CT measurements of lung morphological changes in cystic fibrosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2015to 6 Sep 2017
- 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
- cystic fibrosis adults
- written informed consent
Who cannot join
- Subjects without any social security or health insurance
- Pregnancy
- MRI contraindications: Magnetically activated implanted devices (cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants), metal inside the eye or the brain (aneurysm clip, ocular foreign body), cardiac valvular prosthesis (Starr-Edwards pre-6000), subject with claustrophobia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Lung Involvement in Cystic Fibrosis Patients Using 1.5T MR Imaging With Ultrashort Echo Time (UTE) Pulse Sequences
Non-invasive assessment of lung involvement is a crucial issue for the follow-up of cystic fibrosis patients. Currently, CT is the method of reference to evaluate and quantify the lung morphological changes in cystic fibrosis adults but it remains a radiation-based technique. MRI with ultrashort echo time (UTE) pulse sequences is a promising non-ionizing alternative for lung imaging. The investigators' objective is to evaluate cystic fibrosis lung involvement using CT and MRI-UTE, and to test the agreement between both techniques.
Read the detailed description
Cystic fibrosis is a recessive autosomic fatal disease, affecting about 6000 people in France. Thanks to progress in symptomatic care, median survival is increasing. The lung involvement is the most common and responsible for most deaths. The evaluation of respiratory disease severity is based on pulmonary functional tests (PFT) and imaging. Multi-slice computed tomography (CT) is the method of reference to quantify lung involvement in cystic fibrosis. It detects respiratory lung involvement earlier than PFT, and it reveals lesions associated with the onset of respiratory exacerbations, the mortality increase and the reduction of quality of life. However CT provides ionizing radiation, thus limiting the possibility of long-term follow-up. MRI is a non-ionizing 3D imaging technique; nevertheless, lung MRI is technically challenging with the result that it is currently not used in routine practice. Indeed, both low proton density and susceptibility effects lead to very low signal intensity derived from lung parenchyma. Recently, pulse sequences with ultrashort echo time (UTE) have been implemented by the use of half radio-frequency excitations and radial projection reconstruction. These UTE sequences make it theoretically possible to retrieve more signal from the lung parenchyma. The investigators aim at using 3D T1-weighted UTE pulse sequences on a 1.5T magnet (Avanto dot, Siemens) in cystic fibrosis patients in order to assess lung involvement severity. Thirty three cystic fibrosis adults are expected to take part in the study. All will benefit from PFT, CT and MRI. The investigators' strategy is to establish a semi quantitative score of pulmonary severity (Helbich score) using MRI and CT in subjects, testing for correlations between MRI and CT measurements and assessing the reproducibility of lung lesions quantification using MRI. The investigators' objective is to demonstrate that MRI-UTE pulse sequence at 1.5T is accurate and reproducible in evaluating and quantifying pulmonary involvement in cystic fibrosis.
- Conditions
- Cystic Fibrosis
- Being tested
- MR measurements of lung morphological changes in cystic fibrosis (Avanto dot, Siemens), CT measurements of lung morphological changes in cystic fibrosis
- Keywords
- Cystic fibrosis, MRI, UTE, CT, Exacerbation, Quality of life, Pulmonary function
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR measurements of lung morphological changes in cystic fibrosis (Avanto dot, Siemens)Device
CT measurements of lung morphological changes in cystic fibrosisDevice
| Study group | Role | What they receive |
|---|---|---|
| Cystic fibrosis adults | Experimental | Not described Receives: Device: MR measurements of lung morphological changes in cystic fibrosis (Avanto dot, Siemens); Device: CT measurements of lung morphological changes in cystic fibrosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between MRI and CT for scoring lung involvement in cystic fibrosis
MRI and CT evaluation of lung lesions quantification in cystic fibrosis will be assessed by 2 blind radiologists.
Agreement between both evaluation will be assessed during statistical analyses after study completion.
Measured: During MRI and CT, Day one
Secondary outcomes (6)
Cystic fibrosis lesions scoring extracted from CT and MR images
MRI and CT evaluation of lung lesions quantification in cystic fibrosis will be assessed by 2 blind radiologists.
Agreement between both evaluation will be assessed during statistical analyses after study completion.
Measured: During MRI and CT, Day one
MRI cystic fibrosis reproductibility scoring over the time
MRI cystic fibrosis scoring will be assessed a second time the same blind radiologist
Measured: During MRI, Day one
Correlation between MRI cystic fibrosis scoring and PFT indexes
Measured: Day one
Correlation between MRI cystic fibrosis scoring and exacerbation number
Measured: 12 month after Day one
Correlation between MRI cystic fibrosis scoring and quality of life
Measured: Day one and 12 month after Day one
Evolution of MRI cystic fibrosis scoring after one year
Measured: 12 month after Day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study start30 Sep 2015
- Primary completion6 Sep 2016
- Study completion6 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 University Hospital, BordeauxThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449785
- Sponsor's protocol ID
- CHUBX2014/11
- Acronym
- MucoIRM
- Status last verified
- Nov 2017
- First submitted
- 13 May 2015
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Benlala I, Point S, Leung C, Berger P, Woods JC, Raherison C, Laurent F, Macey J, Dournes G. Volumetric quantification of lung MR signal intensities using ultrashort TE as an automated score in cystic fibrosis. Eur Radiol. 2020 Oct;30(10):5479-5488. doi: 10.1007/s00330-020-06910-w. Epub 2020 May 15.
PubMed 32415586
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Lung Involvement in Cystic Fibrosis Patients Using 1.5T MR Imaging With Ultrashort Echo Time (UTE) Pulse Sequences
- ClinicalTrials.gov ID
- NCT02449785
- Acronym / sponsor ID
- MucoIRM / CHUBX2014/11
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, MRI, UTE, CT, Exacerbation, Quality of life, Pulmonary function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 30 Sep 2015 (actual)
- Primary completion
- 6 Sep 2016 (actual)
- Study completion
- 6 Sep 2017 (actual)
- First posted
- 20 May 2015 (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.
Non-invasive assessment of lung involvement is a crucial issue for the follow-up of cystic fibrosis patients. Currently, CT is the method of reference to evaluate and quantify the lung morphological changes in cystic fibrosis adults but it remains a radiation-based technique. MRI with ultrashort echo time (UTE) pulse sequences is a promising non-ionizing alternative for lung imaging. The investigators' objective is to evaluate cystic fibrosis lung involvement using CT and MRI-UTE, and to test the agreement between both techniques.
Detailed description
Cystic fibrosis is a recessive autosomic fatal disease, affecting about 6000 people in France. Thanks to progress in symptomatic care, median survival is increasing. The lung involvement is the most common and responsible for most deaths. The evaluation of respiratory disease severity is based on pulmonary functional tests (PFT) and imaging. Multi-slice computed tomography (CT) is the method of reference to quantify lung involvement in cystic fibrosis. It detects respiratory lung involvement earlier than PFT, and it reveals lesions associated with the onset of respiratory exacerbations, the mortality increase and the reduction of quality of life. However CT provides ionizing radiation, thus limiting the possibility of long-term follow-up. MRI is a non-ionizing 3D imaging technique; nevertheless, lung MRI is technically challenging with the result that it is currently not used in routine practice. Indeed, both low proton density and susceptibility effects lead to very low signal intensity derived from lung parenchyma. Recently, pulse sequences with ultrashort echo time (UTE) have been implemented by the use of half radio-frequency excitations and radial projection reconstruction. These UTE sequences make it theoretically possible to retrieve more signal from the lung parenchyma. The investigators aim at using 3D T1-weighted UTE pulse sequences on a 1.5T magnet (Avanto dot, Siemens) in cystic fibrosis patients in order to assess lung involvement severity. Thirty three cystic fibrosis adults are expected to take part in the study. All will benefit from PFT, CT and MRI. The investigators' strategy is to establish a semi quantitative score of pulmonary severity (Helbich score) using MRI and CT in subjects, testing for correlations between MRI and CT measurements and assessing the reproducibility of lung lesions quantification using MRI. The investigators' objective is to demonstrate that MRI-UTE pulse sequence at 1.5T is accurate and reproducible in evaluating and quantifying pulmonary involvement in cystic fibrosis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cystic fibrosis adults | Experimental | Device: MR measurements of lung morphological changes in cystic fibrosis (Avanto dot, Siemens), Device: CT measurements of lung morphological changes in cystic fibrosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- cystic fibrosis adults
- written informed consent
Key exclusion criteria (3 listed)
- Subjects without any social security or health insurance
- Pregnancy
- MRI contraindications: Magnetically activated implanted devices (cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants), metal inside the eye or the brain (aneurysm clip, ocular foreign body), cardiac valvular prosthesis (Starr-Edwards pre-6000), subject with claustrophobia.
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 |
|---|---|---|
| MR measurements of lung morphological changes in cystic fibrosis (Avanto dot, Siemens) | Device | Cystic fibrosis adults |
| CT measurements of lung morphological changes in cystic fibrosis | Device | Cystic fibrosis adults |
Primary outcome
Agreement between MRI and CT for scoring lung involvement in cystic fibrosis
Time frame: During MRI and CT, Day one
MRI and CT evaluation of lung lesions quantification in cystic fibrosis will be assessed by 2 blind radiologists. Agreement between both evaluation will be assessed during statistical analyses after study completion.
6 secondary outcomes
Cystic fibrosis lesions scoring extracted from CT and MR images
Time frame: During MRI and CT, Day one
MRI cystic fibrosis reproductibility scoring over the time
Time frame: During MRI, Day one
Correlation between MRI cystic fibrosis scoring and PFT indexes
Time frame: Day one
Correlation between MRI cystic fibrosis scoring and exacerbation number
Time frame: 12 month after Day one
Correlation between MRI cystic fibrosis scoring and quality of life
Time frame: Day one and 12 month after Day one
Evolution of MRI cystic fibrosis scoring after one year
Time frame: 12 month after Day one
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 27 Nov 2017.
- Derived from this study: PubMed 32415586Benlala I, Point S, Leung C, Berger P, Woods JC, Raherison C, Laurent F, Macey J, Dournes G. Volumetric quantification of lung MR signal intensities using ultrashort TE as an automated score in cystic fibrosis. Eur Radiol. 2020 Oct;30(10):5479-5488. doi: 10.1007/s00330-020-06910-w. Epub 2020 May 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR measurements of lung morphological changes in cystic fibrosis (Avanto dot, Siemens) and CT measurements of lung morphological changes in cystic fibrosis in people with Cystic Fibrosis, run by University Hospital, Bordeaux 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 2 inclusion and 3 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 27 Nov 2017. 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?
Agreement between MRI and CT for scoring lung involvement in cystic fibrosis (time frame: During MRI and CT, Day one). 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 NCT02449785, which also lists 1 linked publication.
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 27 Nov 2017.