- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02163681
MRI for Non-Invasive Imaging in Neonates and Children
March 24, 2022 updated by: Y. Michael Shim, MD, University of Virginia
MRI as a Means to Measure Lung Function: Non-Invasive Imaging in Neonates and Young Children
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia Health System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 months to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hyperpolarized Helium 3 MRI of the chest
Using hyperpolarized helium-3 as an inhaled contrast agent for MRI, we will assess the lung ventilation.
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hyperpolarized helium-3 is an inhaled gaseous contrast agent for MRI and permits the acquisition of high quality imagined of lung ventilation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ventilation Defects as Seen on Hyperpolarized Helium-3 MRI
Time Frame: Day 1
|
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.
|
Day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2011
Primary Completion (Actual)
June 30, 2018
Study Completion (Actual)
July 30, 2018
Study Registration Dates
First Submitted
June 10, 2014
First Submitted That Met QC Criteria
June 11, 2014
First Posted (Estimate)
June 16, 2014
Study Record Updates
Last Update Posted (Actual)
April 19, 2022
Last Update Submitted That Met QC Criteria
March 24, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15720
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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