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Thorax MRI for Evaluation of Lung Morphology, Ventilation and Perfusion

Primary Purpose

Lung Diseases, Interstitial Lung Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
MRI of the chest
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Zurich - Diagnostic Radiology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All patients

Arm Description

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

Outcomes

Primary Outcome Measures

Lung Morphology
Value of static MR-images compared to CT.

Secondary Outcome Measures

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

Full Information

First Posted
January 20, 2021
Last Updated
May 10, 2023
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT04719078
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Interstitial Lung Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All patients
Arm Type
Other
Arm Description
There are no study arms. All patients obtain all imaging modalities.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI of the chest
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lung Morphology
Description
Value of static MR-images compared to CT.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Lung function
Description
Correlation of functional MR with lung function ventilation/perfusion compared to CT.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University Hospital Zurich - Diagnostic Radiology
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Thorax MRI for Evaluation of Lung Morphology, Ventilation and Perfusion

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