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
About this trial
This is an interventional diagnostic trial for Lung Diseases
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
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
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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