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

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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

Tracking Information
First Submitted Date  ICMJE June 10, 2014
First Posted Date  ICMJE June 16, 2014
Last Update Posted Date October 19, 2017
Actual Study Start Date  ICMJE January 2011
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
Ventilation Defects as seen on Hyperpolarized helium-3 MRI [ Time Frame: Day 1 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MRI as a Means to Measure Lung Function: Non-Invasive Imaging in Neonates and Children
Official Title  ICMJE Not Provided
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Healthy
  • Cystic Fibrosis (CF)
  • Asthma
  • Bronchopulmonary Dysplasia (BPD)
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Drug: Hyperpolarized Helium-3 MRI of the chest
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 11, 2014)
77
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Months to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02163681
Other Study ID Numbers  ICMJE 15720
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Y. Michael Shim, MD, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE Xemed LLC
Investigators  ICMJE Not Provided
PRS Account University of Virginia
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP