Thorax MRI for Evaluation of Lung Morphology, Ventilation and Perfusion

Prospective Assessment of MRI for Morphological and Functional Imaging in the Thorax.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Diseases; Interstitial Lung Disease
• Intervention / Treatment: Diagnostic test: MRI of the chest

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich - Diagnostic Radiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: All patients; There are no study arms. All patients obtain all imaging modalities.

Diagnostic test: MRI of the chest; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung Morphology	Value of static MR-images compared to CT.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung function	Correlation of functional MR with lung function ventilation/perfusion compared to CT.	2 years

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: MR 02

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