Idiopathic Pulmonary FibrosisPIC'IRMNCT03078426
Lung MRI in the Management of Idiopathic Pulmonary Fibrosis
A study testing MRI and Thoracic HRCT (standard reference) in people with Idiopathic Pulmonary Fibrosis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
High resolution computed tomography (HRCT) plays a major role in the management of idiopathic pulmonary fibrosis (IPF) by identifying characteristic lesions of usual interstitial pneumonia (UIP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- MRI and Thoracic HRCT (standard reference)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2017to 14 Feb 2020
- 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
- Patients > 18 years old followed in Bordeaux University Hospital
- Patients with a definite diagnosis of IPF :
- Based on a "certain" UIP pattern at HRCT without histopathology
- Based on a "possible" UIP pattern at HRCT with histopathology given by surgical lung biopsy.
- Patients with a diagnosis of fibrosing sarcoidosis after multidisciplinary discussion
- Patients with a diagnosis of acute or sub-acute hypersensitivity pneumonitis after multidisciplinary discussion
Show all 11Show fewer
- Patients diagnosed with organizing pneumonia after multidisciplinary discussion
- Patients with a diagnosis of isolated pleural plaques after multidisciplinary discussion
- Patient able to withstand supine position for more than 30 minutes
- Patient affiliated to a social security system
- Patients who gave their written informed consent
Who cannot join
- Subject detained by judicial or administrative decision.
- Major protected by law.
- Subject not affiliated to a social security care
- Subject in period of relative exclusion in relation to another protocol.
- Patients with specific contraindication to undergoing MRI: iron material, a heart pacemaker, claustrophobia, gadolinium hypersensitivity, renal impairment with glomerular filtration rate less than 30 mL/min, pregnant or nursing woman.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LUNG MRI in the Management of Idiopathic Pulmonary Fibrosis : PIC'IRM
High resolution computed tomography (HRCT) plays a major role in the management of idiopathic pulmonary fibrosis (IPF) by identifying characteristic lesions of usual interstitial pneumonia (UIP). Though HRCT is the standard reference to describe pulmonary structural alterations using a non invasive technique, it is nonetheless a radiating exam which provides limited functional information regarding inflammation. In this trial, the investigators aimed to evaluate whether MRI (Magnetic Resonance Imaging) using ultra-short echotime could be an alternative to HRCT in the assessment of the four morphological criteria required to define an UIP pattern. The investigators also planned to study the clinical value of the additional informations derived from MRI such as contrasts and lung perfusion using functional MRI.
Read the detailed description
High resolution computed tomography (HRCT) is an essential component in the diagnostic pathway of idiopathic pulmonary fibrosis (IPF). With the appropriate clinical setting, the presence of an usual interstitial pneumonia (UIP) pattern on HRCT is sufficient to diagnose IPF. Four morphological criteria are required: (1) Subpleural, basal predominance, (2) Reticular abnormality, (3) Honeycombing with or without traction bronchiectasis, (4) Absence of features inconsistent with UIP pattern. However, HRCT is a radiating technique and only give data about structural alterations. Recent advances in three-dimensional ultra-short echo time (3D-UTE) imaging have shown promising results in improving lung MR (Magnetic Resonance) imaging quality. Since HRCT is the standard reference in IPF, the investigators aimed to evaluate whether thoracic MRI could be an alternative to HRCT in the assessment of the four radiologic criteria required for the diagnosis of IPF. Moreover, thoracic MRI could give new functional data, expected to relate to lung inflammation.
In order to study the diagnostic's accuracy of MRI for each radiological criteria defining UIP pattern, the investigators will compare HRCT and thoracic MRI of patients with IPF to HRCT and thoracic MRI of patients with other lung diseases that do not have all the UIP criteria.
Study procedure will be gadolinium-enhanced PETRA (pointwise encoding time reduction with radial acquisition) MR sequencing compared to unenhanced HRCT within 15 days. No follow-up is needed.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- MRI, Thoracic HRCT (standard reference)
- Keywords
- Lung, MRI, CT, Usual interstitial pneumonia, Ultra-short echo time
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
It will be performed on a 1.5-Tesla MR scanner (MAGNETOM Avanto, Siemens Healthcare, Erlangen, Germany). Acquisitions will be obtained in the axial plane using a 12-channel thorax/spine coil. Investigators will use previously published sequence parameters for each MRI sequence. PETRA will be acquired under free-breathing with respiratory gating at functional respiratory capacity.
Thoracic HRCT (standard reference)Other
It will be performed on a 16 (Sensation 16, Siemens®) or 64 channels (Definition 64, Siemens®), without contrast agent injection.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : UIP pattern | Experimental | 18 patients with UIP pattern at HRCT and IPF as a definite diagnosis. Receives: Device: MRI; Other: Thoracic HRCT (standard reference) |
| Group 2 : possible UIP pattern | Experimental | 7 patients with " possible " UIP pattern at HRCT with histopathology given by surgical lung biopsy making the diagnosis of IPF. Receives: Device: MRI; Other: Thoracic HRCT (standard reference) |
| Group 3 : diagnosis of fibrosing sarcoidosis | Experimental | 15 patients with the diagnosis of fibrosing sarcoidosis after multidisciplinary discussion. Receives: Device: MRI; Other: Thoracic HRCT (standard reference) |
| Group 4 : lung diseases without reticulations | Experimental | 20 patients with lung diseases without reticulations (acute or sub-acute hypersensitivity pneumonitis, organizing pneumonia, isolated pleural plaques) . Receives: Device: MRI; Other: Thoracic HRCT (standard reference) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the diagnostic's accuracy of lung MRI compared to thoracic HRCT
Identifying the four radiologic criteria defining UIP pattern at inclusion (D0): (1) Subpleural, basal predominance, (2) Reticular abnormality, (3) Honeycombing with or without traction bronchiectasis, (4) Absence of features inconsistent with UIP pattern.
Measured: Day 0
Secondary outcomes (11)
Presence of the four radiologic criteria defining UIP pattern in the group of patient with definite diagnosis of IPF but with "possible" UIP pattern.
Measured: Day 0
Correlation between perfusion defects in MRI and IPF severity assessed by pulmonary function test : Forced Vital Capacity (FVC)
Measured: Day 0
Correlation between perfusion defects in MRI and IPF severity assessed by pulmonary function test : Transfer factor of carbon monoxide (TLCO)
Measured: Day 0
Correlation between perfusion defects in MRI and IPF severity assessed by 6 minutes exercise test
Measured: Day 0
Correlation between T2 signal intensity and IPF severity assessed by pulmonary function test : Forced Vital Capacity (FVC)
Measured: Day 0
Correlation between T2 signal intensity and IPF severity assessed by pulmonary function test : Transfer factor of carbon monoxide (TLCO)
Measured: Day 0
Correlation between T2 signal intensity and IPF severity assessed by 6 minutes exercise test
Measured: Day 0
Correlation between gadolinium-enhanced signal and IPF severity assessed by pulmonary function test : Forced Vital Capacity (FVC)
Measured: Day 0
Correlation between gadolinium-enhanced signal and IPF severity assessed by pulmonary function test : Transfer factor of carbon monoxide (TLCO)
Measured: Day 0
Correlation between gadolinium-enhanced signal and IPF severity assessed by 6 minutes exercise test
Measured: Day 0
The interobserver agreement of the results of the MRI will be estimated by the Kappa coefficient
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start16 Feb 2017
- Primary completion14 Feb 2020
- Study completion14 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elodie BLANCHARD, MD, Principal investigator, University Hospital, BordeauxRodolphe THIEBAUT, MD PhD, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078426
- Sponsor's protocol ID
- CHUBX2015/31
- Other IDs
- 2016-A01163-48
- Acronym
- PIC'IRM
- Status last verified
- Feb 2022
- First submitted
- 8 Feb 2017
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUNG MRI in the Management of Idiopathic Pulmonary Fibrosis : PIC'IRM
- ClinicalTrials.gov ID
- NCT03078426
- Acronym / sponsor ID
- PIC'IRM / CHUBX2015/31
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Lung, MRI, CT, Usual interstitial pneumonia, Ultra-short echo time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 13 Mar 2017 (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.
High resolution computed tomography (HRCT) plays a major role in the management of idiopathic pulmonary fibrosis (IPF) by identifying characteristic lesions of usual interstitial pneumonia (UIP). Though HRCT is the standard reference to describe pulmonary structural alterations using a non invasive technique, it is nonetheless a radiating exam which provides limited functional information regarding inflammation. In this trial, the investigators aimed to evaluate whether MRI (Magnetic Resonance Imaging) using ultra-short echotime could be an alternative to HRCT in the assessment of the four morphological criteria required to define an UIP pattern. The investigators also planned to study the clinical value of the additional informations derived from MRI such as contrasts and lung perfusion using functional MRI.
Detailed description
High resolution computed tomography (HRCT) is an essential component in the diagnostic pathway of idiopathic pulmonary fibrosis (IPF). With the appropriate clinical setting, the presence of an usual interstitial pneumonia (UIP) pattern on HRCT is sufficient to diagnose IPF. Four morphological criteria are required: (1) Subpleural, basal predominance, (2) Reticular abnormality, (3) Honeycombing with or without traction bronchiectasis, (4) Absence of features inconsistent with UIP pattern. However, HRCT is a radiating technique and only give data about structural alterations. Recent advances in three-dimensional ultra-short echo time (3D-UTE) imaging have shown promising results in improving lung MR (Magnetic Resonance) imaging quality. Since HRCT is the standard reference in IPF, the investigators aimed to evaluate whether thoracic MRI could be an alternative to HRCT in the assessment of the four radiologic criteria required for the diagnosis of IPF. Moreover, thoracic MRI could give new functional data, expected to relate to lung inflammation.
In order to study the diagnostic's accuracy of MRI for each radiological criteria defining UIP pattern, the investigators will compare HRCT and thoracic MRI of patients with IPF to HRCT and thoracic MRI of patients with other lung diseases that do not have all the UIP criteria.
Study procedure will be gadolinium-enhanced PETRA (pointwise encoding time reduction with radial acquisition) MR sequencing compared to unenhanced HRCT within 15 days. No follow-up is needed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 : UIP pattern | Experimental | Device: MRI, Other: Thoracic HRCT (standard reference)18 patients with UIP pattern at HRCT and IPF as a definite diagnosis. |
| Group 2 : possible UIP pattern | Experimental | Device: MRI, Other: Thoracic HRCT (standard reference)7 patients with " possible " UIP pattern at HRCT with histopathology given by surgical lung biopsy making the diagnosis of IPF. |
| Group 3 : diagnosis of fibrosing sarcoidosis | Experimental | Device: MRI, Other: Thoracic HRCT (standard reference)15 patients with the diagnosis of fibrosing sarcoidosis after multidisciplinary discussion. |
| Group 4 : lung diseases without reticulations | Experimental | Device: MRI, Other: Thoracic HRCT (standard reference)20 patients with lung diseases without reticulations (acute or sub-acute hypersensitivity pneumonitis, organizing pneumonia, isolated pleural plaques) . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients > 18 years old followed in Bordeaux University Hospital
- Patients with a definite diagnosis of IPF :
- Patients with a diagnosis of fibrosing sarcoidosis after multidisciplinary discussion
- Patients with a diagnosis of acute or sub-acute hypersensitivity pneumonitis after multidisciplinary discussion
- Patients diagnosed with organizing pneumonia after multidisciplinary discussion
Key exclusion criteria (5 listed)
- Subject detained by judicial or administrative decision.
- Major protected by law.
- Subject not affiliated to a social security care
- Subject in period of relative exclusion in relation to another protocol.
- Patients with specific contraindication to undergoing MRI: iron material, a heart pacemaker, claustrophobia, gadolinium hypersensitivity, renal impairment with glomerular filtration rate less than 30 mL/min, pregnant or nursing woman.
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 |
|---|---|---|
| MRIIt will be performed on a 1.5-Tesla MR scanner (MAGNETOM Avanto, Siemens Healthcare, Erlangen, Germany). Acquisitions will be obtained in the axial plane using a 12-channel thorax/spine coil. Investigators will use previously published sequence parameters for each MRI sequence. PETRA will be acquired under free-breathing with respiratory gating at functional respiratory capacity. | Device | Group 1 : UIP pattern, Group 2 : possible UIP pattern, Group 3 : diagnosis of fibrosing sarcoidosis, Group 4 : lung diseases without reticulations |
| Thoracic HRCT (standard reference)It will be performed on a 16 (Sensation 16, Siemens®) or 64 channels (Definition 64, Siemens®), without contrast agent injection. | Other | Group 1 : UIP pattern, Group 2 : possible UIP pattern, Group 3 : diagnosis of fibrosing sarcoidosis, Group 4 : lung diseases without reticulations |
Primary outcome
Measure of the diagnostic's accuracy of lung MRI compared to thoracic HRCT
Time frame: Day 0
Identifying the four radiologic criteria defining UIP pattern at inclusion (D0): (1) Subpleural, basal predominance, (2) Reticular abnormality, (3) Honeycombing with or without traction bronchiectasis, (4) Absence of features inconsistent with UIP pattern.
11 secondary outcomes
Presence of the four radiologic criteria defining UIP pattern in the group of patient with definite diagnosis of IPF but with "possible" UIP pattern.
Time frame: Day 0
Correlation between perfusion defects in MRI and IPF severity assessed by pulmonary function test : Forced Vital Capacity (FVC)
Time frame: Day 0
Correlation between perfusion defects in MRI and IPF severity assessed by pulmonary function test : Transfer factor of carbon monoxide (TLCO)
Time frame: Day 0
Correlation between perfusion defects in MRI and IPF severity assessed by 6 minutes exercise test
Time frame: Day 0
Correlation between T2 signal intensity and IPF severity assessed by pulmonary function test : Forced Vital Capacity (FVC)
Time frame: Day 0
Correlation between T2 signal intensity and IPF severity assessed by pulmonary function test : Transfer factor of carbon monoxide (TLCO)
Time frame: Day 0
Correlation between T2 signal intensity and IPF severity assessed by 6 minutes exercise test
Time frame: Day 0
Correlation between gadolinium-enhanced signal and IPF severity assessed by pulmonary function test : Forced Vital Capacity (FVC)
Time frame: Day 0
Correlation between gadolinium-enhanced signal and IPF severity assessed by pulmonary function test : Transfer factor of carbon monoxide (TLCO)
Time frame: Day 0
Correlation between gadolinium-enhanced signal and IPF severity assessed by 6 minutes exercise test
Time frame: Day 0
The interobserver agreement of the results of the MRI will be estimated by the Kappa coefficient
Time frame: Day 0
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 20 May 2026.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
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.
Elodie BLANCHARD, MD principal investigator
University Hospital, Bordeaux
Rodolphe THIEBAUT, MD PhD study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and Thoracic HRCT (standard reference) in people with Idiopathic Pulmonary 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 11 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 20 May 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?
Measure of the diagnostic's accuracy of lung MRI compared to thoracic HRCT (time frame: Day 0). 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 20 May 2026.