Lung MRI in the Management of Idiopathic Pulmonary Fibrosis (PIC'IRM)

May 19, 2026 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pessac, France, 33604
        • CHU de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1 : UIP pattern
18 patients with UIP pattern at HRCT and IPF as a definite diagnosis.
Device: MRI
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.
Other: Thoracic HRCT (standard reference)
It will be performed on a 16 (Sensation 16, Siemens®) or 64 channels (Definition 64, Siemens®), without contrast agent injection.
Experimental: Group 2 : possible UIP pattern
7 patients with " possible " UIP pattern at HRCT with histopathology given by surgical lung biopsy making the diagnosis of IPF.
Device: MRI
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.
Other: Thoracic HRCT (standard reference)
It will be performed on a 16 (Sensation 16, Siemens®) or 64 channels (Definition 64, Siemens®), without contrast agent injection.
Experimental: Group 3 : diagnosis of fibrosing sarcoidosis
15 patients with the diagnosis of fibrosing sarcoidosis after multidisciplinary discussion.
Device: MRI
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.
Other: Thoracic HRCT (standard reference)
It will be performed on a 16 (Sensation 16, Siemens®) or 64 channels (Definition 64, Siemens®), without contrast agent injection.
Experimental: Group 4 : lung diseases without reticulations
20 patients with lung diseases without reticulations (acute or sub-acute hypersensitivity pneumonitis, organizing pneumonia, isolated pleural plaques) .
Device: MRI
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.
Other: Thoracic HRCT (standard reference)
It will be performed on a 16 (Sensation 16, Siemens®) or 64 channels (Definition 64, Siemens®), without contrast agent injection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
Day 0
Correlation between perfusion defects in MRI and IPF severity assessed by pulmonary function test : Forced Vital Capacity (FVC)
Time Frame: Day 0
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
Day 0
Correlation between perfusion defects in MRI and IPF severity assessed by 6 minutes exercise test
Time Frame: Day 0
Day 0
Correlation between T2 signal intensity and IPF severity assessed by pulmonary function test : Forced Vital Capacity (FVC)
Time Frame: Day 0
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
Day 0
Correlation between T2 signal intensity and IPF severity assessed by 6 minutes exercise test
Time Frame: Day 0
Day 0
Correlation between gadolinium-enhanced signal and IPF severity assessed by pulmonary function test : Forced Vital Capacity (FVC)
Time Frame: Day 0
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
Day 0
Correlation between gadolinium-enhanced signal and IPF severity assessed by 6 minutes exercise test
Time Frame: Day 0
Day 0
The interobserver agreement of the results of the MRI will be estimated by the Kappa coefficient
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elodie BLANCHARD, MD, University Hospital, Bordeaux
  • Study Chair: Rodolphe THIEBAUT, MD PhD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 14, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 14, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX2015/31
  • 2016-A01163-48 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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