Clinical trial NCT04719078: Thorax MRI for Evaluation of Lung Morphology, Ventilation and Perfusion
Official title: Prospective Assessment of MRI for Morphological and Functional Imaging in the Thorax.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Diseases
Interstitial Lung Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lung Morphology
timeFrame: 2 years
Secondary outcomes:
measure: Lung function
timeFrame: 2 years
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich - Diagnostic Radiology
Study officials:
References: