Thorax MRI for Evaluation of Lung Morphology, Ventilation and Perfusion

Not Applicable

Not yet recruiting

• Conditions: Interstitial Lung Disease; Lung Diseases
• Interventions: Diagnostic Test: MRI of the chest

• Registration Number: NCT04719078
• Lead Sponsor: University of Zurich

Brief Summary

In spite of the considerable technical difficulties, several publications confirm the potential that T1-maps and MRI to characterize pathological changes in lung tissue. However, existing literature still cannot provide a final evaluation of the presented methods. Study participants won't have any disadvantage in participating the study since all of them undergo next to the MRI-Scan also the two standard methods: CT and lung function test.

In this study the value of chest MR compared to CT and LFT in the evaluation of morphological lung changes and their correlation to lung ventilation and perfusion will be evaluated.

Detailed Description

Patients with interstitial lung disease require an adequate tool for diagnosis and monitoring. Traditionally, the diagnostics are done by CT and lung-function tests. Follow-up of these patients include regular CT-Imaging and LFT to monitor disease progress to visualize possible complications early. Every examination exposes the patient to ionizing radiation, and LFTs alone are not sensitive enough to visualize local changes. Therefore, it is desirable to switch from these two diagnostic tools to a less harm-full and a more sensitive one: MR-Imaging. MR-Imaging allows for a non-invasive and more sensitive illustration of lung morphology as well as local ventilation and perfusion for early detection of lung function alterations without the exposure of the patient to ionizing radiation.

1. Ojective To demonstrate the value of MR-Imaging as a valuable, radiation-free method to visualize lung morphology and pathologic lung changes in patients with interstitial lung diseases quantitatively and qualitatively. A positive result would allow using MR as an additive or alternative method in the assessment of parenchymal lung changes to detect early parenchymal changes as well as to monitor the course of disease, especially for medical treatment.

2. Objective Quantitative and qualitative validation of MR-Imaging in the assessment of local lung ventilation and perfusion compared to lung function tests.

Prospective, single-centre, non-randomised, non-blinded trial with MR-Imaging of patients. All of the patients undergo MR-Imaging as well as the two standard diagnostic procedures: CT and lung function tests.

Inclusion criteria: patients with interstitial lung disease scheduled for CT and LFT, written consent, ≥ 18 years.

Exclusion criteria: claustrophobia and impossibility to lie in the MR for more than 30 minutes, pregnancy, and the generally valid contraindications for MRI.

The study participants will obtain a MRI of the thorax with one of the institutions MR machines (Philips Achieva 1.5T, GE Discovery 3T, MRI Siemens Skyra 3T, and GE SIGNA Artist 1.5T). The study participant will be asked to lie in the MR scanner for about 30 minutes while the images will be acquired. The image acquisition with the above-mentioned MR machines is authorised in Switzerland and the application is done according to the product information.

Study Timeline

• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-22
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-11
• Study Start: 2023-06-01
• Primary Completion: 2023-07-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients with interstitial lung disease scheduled for CT and LFT
• written consent
• ≥ 18 years.

Exclusion Criteria

• claustrophobia
• impossibility to lie in the MR for more than 30 minutes
• pregnancy
• generally valid contraindications for MRI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	MRI of the chest	There are no study arms. All patients obtain all imaging modalities.

Primary Outcome Measures

Name	Time	Method
Lung Morphology	2 years	Value of static MR-images compared to CT.

Secondary Outcome Measures

Name	Time	Method
Lung function	2 years	Correlation of functional MR with lung function ventilation/perfusion compared to CT.

Trial Locations

Locations (1)

University Hospital Zurich - Diagnostic Radiology; 🇨🇭 Zurich, Switzerland