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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Thoracic HRCT (standard reference)
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Idiopathic Pulmonary Fibrosis focused on measuring Lung, MRI, CT, Usual interstitial pneumonia, Ultra-short echo time

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1 : UIP pattern

Group 2 : possible UIP pattern

Group 3 : diagnosis of fibrosing sarcoidosis

Group 4 : lung diseases without reticulations

Arm Description

18 patients with UIP pattern at HRCT and IPF as a definite diagnosis.

7 patients with " possible " UIP pattern at HRCT with histopathology given by surgical lung biopsy making the diagnosis of IPF.

15 patients with the diagnosis of fibrosing sarcoidosis after multidisciplinary discussion.

20 patients with lung diseases without reticulations (acute or sub-acute hypersensitivity pneumonitis, organizing pneumonia, isolated pleural plaques) .

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Presence of the four radiologic criteria defining UIP pattern in the group of patient with definite diagnosis of IPF but with "possible" UIP pattern.
Correlation between perfusion defects in MRI and IPF severity assessed by pulmonary function test : Forced Vital Capacity (FVC)
Correlation between perfusion defects in MRI and IPF severity assessed by pulmonary function test : Transfer factor of carbon monoxide (TLCO)
Correlation between perfusion defects in MRI and IPF severity assessed by 6 minutes exercise test
Correlation between T2 signal intensity and IPF severity assessed by pulmonary function test : Forced Vital Capacity (FVC)
Correlation between T2 signal intensity and IPF severity assessed by pulmonary function test : Transfer factor of carbon monoxide (TLCO)
Correlation between T2 signal intensity and IPF severity assessed by 6 minutes exercise test
Correlation between gadolinium-enhanced signal and IPF severity assessed by pulmonary function test : Forced Vital Capacity (FVC)
Correlation between gadolinium-enhanced signal and IPF severity assessed by pulmonary function test : Transfer factor of carbon monoxide (TLCO)
Correlation between gadolinium-enhanced signal and IPF severity assessed by 6 minutes exercise test
The interobserver agreement of the results of the MRI will be estimated by the Kappa coefficient

Full Information

First Posted
February 8, 2017
Last Updated
February 9, 2022
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT03078426
Brief Title
Lung MRI in the Management of Idiopathic Pulmonary Fibrosis
Acronym
PIC'IRM
Official Title
LUNG MRI in the Management of Idiopathic Pulmonary Fibrosis : PIC'IRM
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 16, 2017 (Actual)
Primary Completion Date
February 14, 2020 (Actual)
Study Completion Date
February 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Lung, MRI, CT, Usual interstitial pneumonia, Ultra-short echo time

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 : UIP pattern
Arm Type
Experimental
Arm Description
18 patients with UIP pattern at HRCT and IPF as a definite diagnosis.
Arm Title
Group 2 : possible UIP pattern
Arm Type
Experimental
Arm Description
7 patients with " possible " UIP pattern at HRCT with histopathology given by surgical lung biopsy making the diagnosis of IPF.
Arm Title
Group 3 : diagnosis of fibrosing sarcoidosis
Arm Type
Experimental
Arm Description
15 patients with the diagnosis of fibrosing sarcoidosis after multidisciplinary discussion.
Arm Title
Group 4 : lung diseases without reticulations
Arm Type
Experimental
Arm Description
20 patients with lung diseases without reticulations (acute or sub-acute hypersensitivity pneumonitis, organizing pneumonia, isolated pleural plaques) .
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Thoracic HRCT (standard reference)
Intervention Description
It will be performed on a 16 (Sensation 16, Siemens®) or 64 channels (Definition 64, Siemens®), without contrast agent injection.
Primary Outcome Measure Information:
Title
Measure of the diagnostic's accuracy of lung MRI compared to thoracic HRCT
Description
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.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
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
Title
Correlation between perfusion defects in MRI and IPF severity assessed by pulmonary function test : Forced Vital Capacity (FVC)
Time Frame
Day 0
Title
Correlation between perfusion defects in MRI and IPF severity assessed by pulmonary function test : Transfer factor of carbon monoxide (TLCO)
Time Frame
Day 0
Title
Correlation between perfusion defects in MRI and IPF severity assessed by 6 minutes exercise test
Time Frame
Day 0
Title
Correlation between T2 signal intensity and IPF severity assessed by pulmonary function test : Forced Vital Capacity (FVC)
Time Frame
Day 0
Title
Correlation between T2 signal intensity and IPF severity assessed by pulmonary function test : Transfer factor of carbon monoxide (TLCO)
Time Frame
Day 0
Title
Correlation between T2 signal intensity and IPF severity assessed by 6 minutes exercise test
Time Frame
Day 0
Title
Correlation between gadolinium-enhanced signal and IPF severity assessed by pulmonary function test : Forced Vital Capacity (FVC)
Time Frame
Day 0
Title
Correlation between gadolinium-enhanced signal and IPF severity assessed by pulmonary function test : Transfer factor of carbon monoxide (TLCO)
Time Frame
Day 0
Title
Correlation between gadolinium-enhanced signal and IPF severity assessed by 6 minutes exercise test
Time Frame
Day 0
Title
The interobserver agreement of the results of the MRI will be estimated by the Kappa coefficient
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elodie BLANCHARD, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rodolphe THIEBAUT, MD PhD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Bordeaux
City
Pessac
ZIP/Postal Code
33604
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Lung MRI in the Management of Idiopathic Pulmonary Fibrosis

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