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MRI as a Means to Measure Lung Function: Non-Invasive Imaging in Neonates and Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163681
Recruitment Status : Unknown
Verified October 2017 by Y. Michael Shim, MD, University of Virginia.
Recruitment status was:  Recruiting
First Posted : June 16, 2014
Last Update Posted : October 19, 2017
Sponsor:
Collaborator:
Xemed LLC
Information provided by (Responsible Party):
Y. Michael Shim, MD, University of Virginia

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.

Condition or disease Intervention/treatment Phase
Healthy Cystic Fibrosis (CF) Asthma Bronchopulmonary Dysplasia (BPD) Drug: Hyperpolarized Helium-3 MRI of the chest Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 77 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Actual Study Start Date : January 2011
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


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.
Drug: Hyperpolarized Helium-3 MRI of the chest
hyperpolarized helium-3 is an inhaled gaseous contrast agent for MRI and permits the acquisition of high quality imagined of lung ventilation.




Primary Outcome Measures :
  1. Ventilation Defects as seen on Hyperpolarized helium-3 MRI [ Time Frame: Day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Months to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163681


Contacts
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Contact: Rachel Dieterich, RN (434) 243-6074 rrd8w@virginia.edu
Contact: Marie D Burdick 434-243-7363 mdb5b@virginia.edu

Locations
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United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Rachel Dieterich, RN    434-243-6074    rrd8w@virginia.edu   
Contact: Marie D Burdick    434-243-7363    mdb5b@virginia.edu   
Principal Investigator: Mike Shim, MD         
Sponsors and Collaborators
University of Virginia
Xemed LLC
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Responsible Party: Y. Michael Shim, MD, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT02163681    
Other Study ID Numbers: 15720
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Cystic Fibrosis
Bronchopulmonary Dysplasia
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Ventilator-Induced Lung Injury
Lung Injury
Infant, Premature, Diseases