Back to resultsMRI for Non-Invasive Imaging in Neonates and Children
Primary Purpose
Healthy, Cystic Fibrosis (CF), Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperpolarized Helium-3 MRI of the chest
Sponsored by
About this trial
This is an interventional basic science trial for Healthy
Eligibility Criteria
Inclusion Criteria:
- MRI sequence development (n=40): Healthy subjects and patients with CF, BPD, or asthma will be used in the development of the rapid imaging techniques. These subjects will be age 4 months to 65 years old. Healthy subjects can have no history of chronic respiratory disease. The subjects with CF or asthma must have a physician diagnosis of their respective disease.
- Proof-of-Concept Study (n=30): Ten healthy infants,10 infants with CF, and 10 infants with BPD age 4-24 months will be imaged in the proof-of-concept study. Healthy infant must have had an uncomplicated term birth and have no history of chronic respiratory symptoms. The patients with CF must have a physician diagnosis of CF and be at their baseline clinical status on the day of imaging.
Exclusion Criteria:
- Any condition for which a MRI procedure is contraindicated.
- Presence of any non-MRI compatible metallic material in the body, such as pacemakers, metallic clips, etc.
- Likelihood of claustrophobia
- Chest circumference greater than that of the helium magnetic resonance (MR) coil.
- Pregnancy, by report of subject. Clinically in the Department of Radiology at UVA, self report is used when screening patients for MR scans as well as CT scans and fluoroscopy studies. If the subject reports there is any chance of their being pregnant a urine pregnancy test will be performed prior to any imaging.
Sites / Locations
- University of Virginia Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hyperpolarized Helium 3 MRI of the chest
Arm Description
Using hyperpolarized helium-3 as an inhaled contrast agent for MRI, we will assess the lung ventilation.
Outcomes
Primary Outcome Measures
Ventilation Defects as Seen on Hyperpolarized Helium-3 MRI
On hyperpolarized helium-3 MRI, well ventilated areas of the lung appear bright and poorly ventilated areas appear dark. The poorly ventilated areas are called ventilation defects. Human readers looked at the hyperpolarized helium-3 MR images and determined whether the lungs had: No Defects, Small Defects, or Large Defects.
Secondary Outcome Measures
Full Information
NCT ID
NCT02163681
First Posted
June 10, 2014
Last Updated
March 24, 2022
Sponsor
University of Virginia
Collaborators
Xemed LLC
1. Study Identification
Unique Protocol Identification Number
NCT02163681
Brief Title
MRI for Non-Invasive Imaging in Neonates and Children
Official Title
MRI as a Means to Measure Lung Function: Non-Invasive Imaging in Neonates and Young Children
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2011 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
Xemed LLC
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to develop rapid MRI techniques for imaging the lung with hyperpolarized helium-3 gas as an inhaled contrast agent. These techniques will be piloted in adults and older children before testing them in younger children and infants. The purpose is to enable imaging of non-sedated infants by imaging so fast as to freeze motion.
Detailed Description
he purpose of this study is to further develop the techniques to permit the imaging of infant lungs with hyperpolarized helium-3 MRI including techniques for acquisition in free breathing infants and infants on a ventilator. We have developed fast imaging techniques and obtained proof-of-concept data in infants as young as 2 months old. Many pediatric lung diseases including CF, bronchopulmonary dysplasia (BPD) and asthma have their origins in infancy so it would be desirable to be able to image infants with hyperpolarized gas MRI. We focused on developing fast imaging techniques to, in essence, freeze lung motion in non-sedated infants. We feel the technique will be more widely adopted if clinically useful images can be obtained without sedating the infant. Some very rapid imaging techniques have been developed for conventional proton MRI for applications such as cardiac MRI that require very short acquisition time. We modified these techniques for use in hyperpolarized gas MRI and developed a technique that permits the acquisition of the entire lung volume of an infant in less than 1 second. These techniques would also be useful for imaging infants who are still on a ventilator with the hope of increasing our understanding of lung development and neonatal lung disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Cystic Fibrosis (CF), Asthma, Bronchopulmonary Dysplasia (BPD)
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hyperpolarized Helium 3 MRI of the chest
Arm Type
Experimental
Arm Description
Using hyperpolarized helium-3 as an inhaled contrast agent for MRI, we will assess the lung ventilation.
Intervention Type
Drug
Intervention Name(s)
Hyperpolarized Helium-3 MRI of the chest
Intervention Description
hyperpolarized helium-3 is an inhaled gaseous contrast agent for MRI and permits the acquisition of high quality imagined of lung ventilation.
Primary Outcome Measure Information:
Title
Ventilation Defects as Seen on Hyperpolarized Helium-3 MRI
Description
On hyperpolarized helium-3 MRI, well ventilated areas of the lung appear bright and poorly ventilated areas appear dark. The poorly ventilated areas are called ventilation defects. Human readers looked at the hyperpolarized helium-3 MR images and determined whether the lungs had: No Defects, Small Defects, or Large Defects.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
MRI sequence development (n=40): Healthy subjects and patients with CF, BPD, or asthma will be used in the development of the rapid imaging techniques. These subjects will be age 4 months to 65 years old. Healthy subjects can have no history of chronic respiratory disease. The subjects with CF or asthma must have a physician diagnosis of their respective disease.
Proof-of-Concept Study (n=30): Ten healthy infants,10 infants with CF, and 10 infants with BPD age 4-24 months will be imaged in the proof-of-concept study. Healthy infant must have had an uncomplicated term birth and have no history of chronic respiratory symptoms. The patients with CF must have a physician diagnosis of CF and be at their baseline clinical status on the day of imaging.
Exclusion Criteria:
Any condition for which a MRI procedure is contraindicated.
Presence of any non-MRI compatible metallic material in the body, such as pacemakers, metallic clips, etc.
Likelihood of claustrophobia
Chest circumference greater than that of the helium magnetic resonance (MR) coil.
Pregnancy, by report of subject. Clinically in the Department of Radiology at UVA, self report is used when screening patients for MR scans as well as CT scans and fluoroscopy studies. If the subject reports there is any chance of their being pregnant a urine pregnancy test will be performed prior to any imaging.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun M Shim, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
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MRI for Non-Invasive Imaging in Neonates and Children
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