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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02163681 |
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Date of registration:
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10/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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MRI as a Means to Measure Lung Function: Non-Invasive Imaging in Neonates and Children
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Scientific title:
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Date of first enrolment:
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January 1, 2011 |
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Target sample size:
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77 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02163681 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Yun M Shim, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Virginia |
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Key inclusion & exclusion criteria
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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.
Age minimum:
4 Months
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Bronchopulmonary Dysplasia (BPD)
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Cystic Fibrosis (CF)
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Asthma
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Healthy
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Intervention(s)
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Drug: Hyperpolarized Helium-3 MRI of the chest
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Primary Outcome(s)
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Ventilation Defects as seen on Hyperpolarized helium-3 MRI
[Time Frame: Day 1]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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