An interventional study of Hyperpolarized Helium-3 MRI of the chest in Healthy, Cystic Fibrosis (CF) and Asthma, sponsored by University of Virginia. Completed at 1 site in United States. Open to participants aged 4 Months to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-19.
Sponsored by University of Virginia · Not applicable, Interventional, and Basic science
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.
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 45 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
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Exclusion Criteria:
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.
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.
Time frame: Day 1
| Milestone | Hyperpolarized Helium 3 MRI of the Chest |
|---|---|
| Started | 45 |
| Completed | 44 |
| Not completed | 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.
| Participants | Hyperpolarized Helium 3 MRI of the Chest |
|---|---|
| No Defects | 9 |
| Small Defects | 13 |
| Large Defects | 16 |
Collected over 1 week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hyperpolarized Helium 3 MRI of the Chest | 0/44 (0%) | 0/44 (0%) | 5/44 (11.4%) |
| Event | Hyperpolarized Helium 3 MRI of the Chest |
|---|---|
| Upset Stomach/vomiting/gasGastrointestinal disorders | 3/44 |
| Headache/sore throatGeneral disorders | 1/44 |
| FeverGeneral disorders | 1/44 |
| Age, Continuous(years) | Hyperpolarized Helium 3 MRI of the Chest |
|---|---|
| Mean | 5.5 ± 5.0 |
| Sex: Female, Male(Participants) | Hyperpolarized Helium 3 MRI of the Chest |
|---|---|
| Female | 18 |
| Male | 26 |
| Race (NIH/OMB)(Participants) | Hyperpolarized Helium 3 MRI of the Chest |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 10 |
| White | 34 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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