Thorax MRI for Evaluation of Lung Morphology, Ventilation and Perfusion

Sponsor
University of Zurich (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04719078
Collaborator
(none)
100
1
1
26
3.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: MRI of the chest
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Prospective Assessment of MRI for Morphological and Functional Imaging in the Thorax.
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Lung Morphology [2 years]

    Value of static MR-images compared to CT.

Secondary Outcome Measures

  1. Lung function [2 years]

    Correlation of functional MR with lung function ventilation/perfusion compared to CT.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Zurich - Diagnostic Radiology Zurich Switzerland 8091

Sponsors and Collaborators

  • University of Zurich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Zurich
ClinicalTrials.gov Identifier:
NCT04719078
Other Study ID Numbers:
  • MR 02
First Posted:
Jan 22, 2021
Last Update Posted:
Oct 6, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2021