Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT02862418
Status:
RECRUITING
Last Update Posted:
2024-11-20
First Post:
2016-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Imaging of Lungs With a New Type of Magnetic Resonance Imaging (MRI) Called UTE (Ultrashort Echo Time)
Sponsor:
Children's Hospital Medical Center, Cincinnati
Organization:
Study Overview
Official Title:
Lung Imaging With Ultra-short Echo Time MRI
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study has 2 purposes:
1. To learn about new ways to use Magnetic Resonance Imaging (MRI) to take clearer pictures of the lungs. A type of MRI called Ultra Short Echo Time (UTE) will be used as well as traditional MRI.
2. To collect images and health information about lungs that have different kinds of lung diseases to compare to healthy lungs. This collection will help researchers and clinicians to better understand lung variations in health and disease.
This study will involve one MRI session that will take about 10 to 30 minutes and for some participants a breathing test that measures how well the lungs are working. This test is called spirometry.
1. To learn about new ways to use Magnetic Resonance Imaging (MRI) to take clearer pictures of the lungs. A type of MRI called Ultra Short Echo Time (UTE) will be used as well as traditional MRI.
2. To collect images and health information about lungs that have different kinds of lung diseases to compare to healthy lungs. This collection will help researchers and clinicians to better understand lung variations in health and disease.
This study will involve one MRI session that will take about 10 to 30 minutes and for some participants a breathing test that measures how well the lungs are working. This test is called spirometry.
Detailed Description:
Interstitial, obstructive, and rare lung diseases are pulmonary disorders that comprise more than 300 disease entities that are poorly understood, diagnosed, and treated. X-ray computed tomography (CT) is the imaging gold standard and the current clinical practice for imaging lung structure and function of patients. Recent advances in magnetic resonance imaging (MRI) pulse sequences and hardware with ultra short echo times (UTE) have enabled MRI of lung anatomy nearly comparable to CT without the risk of ionizing radiation.
The overreaching goals of this study are:
1. to allow for technical development and validation of UTE MRI sequences as an imaging alternative to CT as well as a future diagnostic tool, and
2. to allow for preliminary UTE data generation for healthy and various disease populations. We anticipate this as being particularly important for data on children where variability is greater due to normal variations in size, age and maturity as well as distinctive differences in expression of lung diseases in pediatrics versus adult populations.
This is a prospective, controlled study for technical development and validation of UTE MRI techniques with normal and disease cohorts. This study will use the standard MRI hardware (FDA approved coils and magnet) but will be developing and refining techniques used in the MRI sequences to obtain UTE images. This refinement includes varying the MRI settings to maximize image signal, to control image contrast, and to develop the software needed to acquire more specialized images for the purpose of improved imaging of the lungs. The data will also be used to collect normative data for comparison with lung pathologies.
Subjects may enroll more than once (with separate consent). For these subjects the MRI information may be used to generate data for in-subject temporal variability in both healthy controls and disease groups.
The overreaching goals of this study are:
1. to allow for technical development and validation of UTE MRI sequences as an imaging alternative to CT as well as a future diagnostic tool, and
2. to allow for preliminary UTE data generation for healthy and various disease populations. We anticipate this as being particularly important for data on children where variability is greater due to normal variations in size, age and maturity as well as distinctive differences in expression of lung diseases in pediatrics versus adult populations.
This is a prospective, controlled study for technical development and validation of UTE MRI techniques with normal and disease cohorts. This study will use the standard MRI hardware (FDA approved coils and magnet) but will be developing and refining techniques used in the MRI sequences to obtain UTE images. This refinement includes varying the MRI settings to maximize image signal, to control image contrast, and to develop the software needed to acquire more specialized images for the purpose of improved imaging of the lungs. The data will also be used to collect normative data for comparison with lung pathologies.
Subjects may enroll more than once (with separate consent). For these subjects the MRI information may be used to generate data for in-subject temporal variability in both healthy controls and disease groups.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: