Lung MRI in the Management of Idiopathic Pulmonary Fibrosis

NCT03078426 | Completed

• 2 other identifiers: CHUBX2015/312016-A01163-48
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Lung; MRI; CT; Usual interstitial pneumonia; Ultra-short echo time

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Day 0

• Correlation between perfusion defects in MRI and IPF severity assessed by pulmonary function test : Forced Vital Capacity (FVC)

  Day 0

• Correlation between perfusion defects in MRI and IPF severity assessed by pulmonary function test : Transfer factor of carbon monoxide (TLCO)

  Day 0

• Correlation between perfusion defects in MRI and IPF severity assessed by 6 minutes exercise test

  Day 0

• Correlation between T2 signal intensity and IPF severity assessed by pulmonary function test : Forced Vital Capacity (FVC)

  Day 0

Study Arms (4)

Group 1 : UIP pattern

EXPERIMENTAL

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

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.

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.

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) .

Device: MRI; Other: Thoracic HRCT (standard reference)

Interventions

MRI DEVICE

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.

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) OTHER

It will be performed on a 16 (Sensation 16, Siemens®) or 64 channels (Definition 64, Siemens®), without contrast agent injection.

Group 1 : UIP pattern; Group 2 : possible UIP pattern; Group 3 : diagnosis of fibrosing sarcoidosis; Group 4 : lung diseases without reticulations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subject detained by judicial or administrative decision.
• Major protected by law.
• Subject not affiliated to a social security care
• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Pessac, 33604, France

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Reference Standards

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Weights and Measures; Investigative Techniques

Study Officials

• Elodie BLANCHARD, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Rodolphe THIEBAUT, MD PhD

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: March 13, 2017
• Study Start: February 16, 2017
• Primary Completion: February 14, 2020
• Study Completion: February 14, 2020
• Last Updated: May 20, 2026

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)